<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750968</url>
  </required_header>
  <id_info>
    <org_study_id>IRB # 116610</org_study_id>
    <nct_id>NCT03750968</nct_id>
  </id_info>
  <brief_title>Lutein &amp; Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects</brief_title>
  <acronym>L-ZIP</acronym>
  <official_title>Lutein &amp; Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paul S. Bernstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a&#xD;
      period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation&#xD;
      with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on&#xD;
      ocular and systemic biomarkers of maternal and infant carotenoid status relative to a&#xD;
      matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3)&#xD;
      newborn infants with the highest systemic and ocular carotenoid status will have more mature&#xD;
      foveal structure.&#xD;
&#xD;
      Mothers will be enrolled in the study during their first trimester, and will take the study&#xD;
      carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of&#xD;
      mothers and infants will be completed within two weeks of the baby's birth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2019</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant</measure>
    <time_frame>up to 13 weeks gestation to birth</time_frame>
    <description>measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant</measure>
    <time_frame>up to 13 weeks gestation to birth</time_frame>
    <description>We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant</measure>
    <time_frame>up to 13 weeks gestation to birth</time_frame>
    <description>Maternal skin carotenoid levels are measured in Raman units.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density</measure>
    <time_frame>Birth</time_frame>
    <description>Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography</measure>
    <time_frame>Birth</time_frame>
    <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy</measure>
    <time_frame>Birth</time_frame>
    <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Nutrient Deficiency</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Carotenoid group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carotenoid Group</intervention_name>
    <description>Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
    <arm_group_label>Carotenoid group</arm_group_label>
    <other_name>Softgel with lutein and zeaxanthin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Placebo ingredients: Safflower oil</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Softgel without lutein and zeaxanthin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated&#xD;
             obstetric history and plan to deliver either vaginally or by Caesarian section at the&#xD;
             University of Utah for their current pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have regularly taken carotenoid supplements containing more than 0.5 mg of&#xD;
             lutein and/or zeaxanthin daily during the six months prior to screening&#xD;
&#xD;
          -  Women who have significant eye disease associated with macular pigment abnormalities&#xD;
             such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).&#xD;
&#xD;
          -  Women with conditions associated with high-risk pregnancy such as adolescent&#xD;
             pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia,&#xD;
             previous premature delivery, drug abuse or other significant medical illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul S Bernstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Moran Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah John A. Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>May 3, 2023</results_first_submitted>
  <results_first_submitted_qc>June 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2023</results_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Paul S. Bernstein</investigator_full_name>
    <investigator_title>Professor, Ophthalmology/Visual Sciences</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotenoids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03750968/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 12, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03750968/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Only mothers were considered enrolled. One infant and one mother were considered one unit. The enrollment number and number of participants started/completed represents the number of dyads.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Carotenoid Group</title>
          <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24">By definition, only mothers carrying one infant were included in the study. 24 mothers enrolled in the study were assigned to the carotenoid group and out of that, only 21 completed the study. The mother and infant were considered one unit. The 21 mothers and their infants were used for statistical analysis.</participants>
                <participants group_id="P2" count="23">By definition, only mothers carrying one infant were included in the study. 23 mothers enrolled in the study were assigned to the control group and out of that, only 20 completed the study. The mother and infant were considered one unit. The 20 mothers and their infants were used for statistical analysis.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data were derived from the mothers. Participants who did not complete the final study visit were not included in the analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Carotenoid Group</title>
          <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.8" spread="3.1"/>
                    <measurement group_id="B2" value="29.1" spread="3.7"/>
                    <measurement group_id="B3" value="29.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal macular carotenoid levels</title>
          <description>Macular pigment optical volume is a unitless measure. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>Participants who did not complete a final study visit were excluded from final data analysis.</population>
          <units>unitless</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8809" spread="3001"/>
                    <measurement group_id="B2" value="7002" spread="2502"/>
                    <measurement group_id="B3" value="7906" spread="2883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal skin carotenoid levels</title>
          <description>Skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <units>Raman units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39981" spread="9495"/>
                    <measurement group_id="B2" value="39436" spread="8733"/>
                    <measurement group_id="B3" value="39709" spread="9021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal serum carotenoid levels</title>
          <description>We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml).</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="257.6" spread="116.7"/>
                    <measurement group_id="B2" value="217.0" spread="82.5"/>
                    <measurement group_id="B3" value="237.3" spread="102.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated dietary intake of lutein and zeaxanthin</title>
          <description>Estimated dietary intake of lutein and zeaxanthin combined is measured in milligrams per day (mg/day). At each study visit, mothers completed the lutein zeaxanthin questionnaire (LZQ™) quantitative food frequency questionnaire that captures ~ 90% of the lutein/zeaxanthin foods consumed in the USA, based on the National Health and Nutrition Examination Survey (NHANES) data.</description>
          <units>mg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" spread="5.9"/>
                    <measurement group_id="B2" value="3.6" spread="3.1"/>
                    <measurement group_id="B3" value="4.0" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking habit</title>
          <description>Smoking habit is measured on a per participant basis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol intake frequency</title>
          <description>Alcohol intake frequency is measured on per participant basis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Occasional</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <description>Unit of measurement is kilogram per meter squared (kg/m^2).</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.9" spread="3.7"/>
                    <measurement group_id="B2" value="25.4" spread="4.6"/>
                    <measurement group_id="B3" value="24.7" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant</title>
        <description>measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
        <time_frame>up to 13 weeks gestation to birth</time_frame>
        <population>Participants who did not complete the final study visit were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant</title>
          <description>measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>Participants who did not complete the final study visit were not included in the analysis.</population>
          <units>unitless</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12244" spread="688"/>
                    <measurement group_id="O2" value="7343" spread="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant</title>
        <description>We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
        <time_frame>up to 13 weeks gestation to birth</time_frame>
        <population>Participants who did not complete the final study visit were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant</title>
          <description>We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>Participants who did not complete the final study visit were not included in the analysis.</population>
          <units>Nanograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1030.2" spread="86.8"/>
                    <measurement group_id="O2" value="252.0" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant</title>
        <description>Maternal skin carotenoid levels are measured in Raman units.</description>
        <time_frame>up to 13 weeks gestation to birth</time_frame>
        <population>Participants who did not complete a final study visit were excluded from final data analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant</title>
          <description>Maternal skin carotenoid levels are measured in Raman units.</description>
          <population>Participants who did not complete a final study visit were excluded from final data analysis.</population>
          <units>Raman units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55419" spread="2421"/>
                    <measurement group_id="O2" value="38475" spread="1932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density</title>
        <description>Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
        <time_frame>Birth</time_frame>
        <population>We report macular pigment optical density for infants whose mothers consented to ophthalmic imaging for their infant.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density</title>
          <description>Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>We report macular pigment optical density for infants whose mothers consented to ophthalmic imaging for their infant.</population>
          <units>unitless</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.01"/>
                    <measurement group_id="O2" value="0.04" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography</title>
        <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
        <time_frame>Birth</time_frame>
        <population>We report data on infants for whom we were able to obtain a blood sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography</title>
          <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>We report data on infants for whom we were able to obtain a blood sample.</population>
          <units>nanograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="270.5" spread="29.1"/>
                    <measurement group_id="O2" value="54.5" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy</title>
        <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
        <time_frame>Birth</time_frame>
        <population>We report data on infants for whom we were able to obtain skin carotenoid measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>Carotenoid Group</title>
            <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy</title>
          <description>Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2</description>
          <population>We report data on infants for whom we were able to obtain skin carotenoid measurements.</population>
          <units>Raman units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31656" spread="1279"/>
                    <measurement group_id="O2" value="23011" spread="869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Carotenoid Group</title>
          <description>The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Mother and infant are considered one unit enrolled in the Carotenoid group.&#xD;
Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil. Mother and infant are considered one unit enrolled in the Control group.&#xD;
Control Group: Placebo ingredients: Safflower oil</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Down syndrome</sub_title>
                <description>One infant in the carotenoid group was diagnosed with down syndrome at six weeks of age, which was confirmed by genetic testing. This adverse event originated before study enrollment and was therefore unrelated to the study intervention.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Multiple congenital abnormalities</sub_title>
                <description>One infant in the carotenoid group was born prematurely with congenital abnormalities. This adverse event originated before study enrollment and was therefore unrelated to the study intervention.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Nose laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Gestational diabetes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Gestational hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Exacerbated acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Torn placenta at delivery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Preterm delivery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A limitation of this study was its lack of participant racial, ethnic and socioeconomic diversity. Also, by design, this first-in-humans, randomized clinical trial was limited to low-risk pregnancies. Due to funding and logistical limitations, we could not follow the mothers and their infants beyond their postpartum visit. This meant we were not able to assess the role of maternal breastmilk as a continued source of lutein an zeaxanthin during the first months of life.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Paul Bernstein, MD, PhD</name_or_title>
      <organization>University of Utah John A. Moran Eye Center</organization>
      <phone>801-581-4069</phone>
      <email>Paul.Bernstein@hsc.utah.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750968
org study id: IRB # 116610
nct id: NCT03750968
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a
      period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation
      with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on
      ocular and systemic biomarkers of maternal and infant carotenoid status relative to a
      matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3)
      newborn infants with the highest systemic and ocular carotenoid status will have more mature
      foveal structure.

      Mothers will be enrolled in the study during their first trimester, and will take the study
      carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of
      mothers and infants will be completed within two weeks of the baby's birth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
time frame: up to 13 weeks gestation to birth
description: measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
measure: Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant
time frame: up to 13 weeks gestation to birth
description: We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
measure: Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant
time frame: up to 13 weeks gestation to birth
description: Maternal skin carotenoid levels are measured in Raman units.
measure: Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density
time frame: Birth
description: Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
measure: Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography
time frame: Birth
description: Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
measure: Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy
time frame: Birth
description: Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
arm group label: Carotenoid group
arm group type: Experimental
description: The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.
arm group label: Control group
arm group type: Active Comparator
description: The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.
intervention type: Drug
intervention name: Carotenoid Group
description: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil
arm group label: Carotenoid group
other name: Softgel with lutein and zeaxanthin
intervention type: Dietary Supplement
intervention name: Control Group
description: Placebo ingredients: Safflower oil
arm group label: Control group
other name: Softgel without lutein and zeaxanthin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul S Bernstein, MD, PhD
role: Principal Investigator
affiliation: University of Utah Moran Eye Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Utah
investigator full name: Paul S. Bernstein
investigator title: Professor, Ophthalmology/Visual Sciences
mesh term: Carotenoids
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A limitation of this study was its lack of participant racial, ethnic and socioeconomic diversity. Also, by design, this first-in-humans, randomized clinical trial was limited to low-risk pregnancies. Due to funding and logistical limitations, we could not follow the mothers and their infants beyond their postpartum visit. This meant we were not able to assess the role of maternal breastmilk as a continued source of lutein an zeaxanthin during the first months of life.
point of contact: 