<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/NCT02219399</url>
  </required_header>
  <id_info>
    <org_study_id>00186H</org_study_id>
    <nct_id>NCT02219399</nct_id>
  </id_info>
  <brief_title>DHA Supplementation and Pregnancy Outcome</brief_title>
  <official_title>Maternal DHA Supplementation and Pregnancy Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supplementation with DHA during pregnancy will increase gestational length and improve&#xD;
      cognitive development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a trial of supplementation with DHA during pregnancy to increase gestational length.&#xD;
      Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from&#xD;
      week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data&#xD;
      were collected and infants growth at 2 and 4 months and cognitive development at 4 months and&#xD;
      1 year were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2004</primary_completion_date>
  <phase>N/A</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational Length</measure>
    <time_frame>13 weeks</time_frame>
    <description>Length of gestation as measured by Last menstrual period method and US</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Development</measure>
    <time_frame>4 months</time_frame>
    <description>Bayley's Scales of Infant Development measured at 4 months of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Development</measure>
    <time_frame>12 months</time_frame>
    <description>Bayley's Scales of Infant Development measured at 12 months of age</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant birth length</measure>
    <time_frame>13 weeks</time_frame>
    <description>self-explanatory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Growth Velocity</measure>
    <time_frame>2 months to 4 months of age</time_frame>
    <description>Change in infant length and weight from 2 to 4 months of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant birth weight</measure>
    <time_frame>13 weeks</time_frame>
    <description>self-explanatory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant head circumference at birth</measure>
    <time_frame>13 weeks</time_frame>
    <description>self-explanatory</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">871</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>300 mg DHA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg DHA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>olive oil or high oleic acid sunflower oil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>600 mg DHA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600 mg DHA</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>600 mg DHA</intervention_name>
    <description>Pregnant women were given 600 mg DHA in the last trimester of pregnancy</description>
    <arm_group_label>600 mg DHA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>300 mg DHA</intervention_name>
    <description>Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding</description>
    <arm_group_label>300 mg DHA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cervical incompetence&#xD;
&#xD;
          -  presence of cervical cerclage&#xD;
&#xD;
          -  placenta previa&#xD;
&#xD;
          -  intrauterine infection&#xD;
&#xD;
          -  known substance abuse&#xD;
&#xD;
          -  multiple fetuses&#xD;
&#xD;
          -  current pre-eclampsia&#xD;
&#xD;
          -  preexisting diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary A Harris, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health Hospitals and Clinics</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado State University</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>DHA</keyword>
  <keyword>Gestational Length</keyword>
  <keyword>Cognitive Development</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02219399
org study id: 00186H
nct id: NCT02219399
lead sponsor: 
collaborator: 
has dmc: No
Supplementation with DHA during pregnancy will increase gestational length and improve
      cognitive development.
This was a trial of supplementation with DHA during pregnancy to increase gestational length.
      Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from
      week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data
      were collected and infants growth at 2 and 4 months and cognitive development at 4 months and
      1 year were measured.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gestational Length
time frame: 13 weeks
description: Length of gestation as measured by Last menstrual period method and US
measure: Cognitive Development
time frame: 4 months
description: Bayley's Scales of Infant Development measured at 4 months of age
measure: Cognitive Development
time frame: 12 months
description: Bayley's Scales of Infant Development measured at 12 months of age
measure: Infant birth length
time frame: 13 weeks
description: self-explanatory
measure: Infant Growth Velocity
time frame: 2 months to 4 months of age
description: Change in infant length and weight from 2 to 4 months of age
measure: Infant birth weight
time frame: 13 weeks
description: self-explanatory
measure: Infant head circumference at birth
time frame: 13 weeks
description: self-explanatory
arm group label: 300 mg DHA
arm group type: Experimental
description: 300 mg DHA
arm group label: Placebo
arm group type: Placebo Comparator
description: olive oil or high oleic acid sunflower oil placebo
arm group label: 600 mg DHA
arm group type: Experimental
description: 600 mg DHA
intervention type: Dietary Supplement
intervention name: 600 mg DHA
description: Pregnant women were given 600 mg DHA in the last trimester of pregnancy
arm group label: 600 mg DHA
intervention type: Dietary Supplement
intervention name: 300 mg DHA
description: Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding
arm group label: 300 mg DHA
intervention type: Dietary Supplement
intervention name: Placebo
description: Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mary A Harris, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
facility: 
country: United States
responsible party type: Sponsor