<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/NCT04462939</url>
  </required_header>
  <id_info>
    <org_study_id>18737</org_study_id>
    <nct_id>NCT04462939</nct_id>
  </id_info>
  <brief_title>Study to Learn About the Effect of Elevit (a Food Supplement Containing Several Vitamins, Minerals, Lutein and DHA) on the Nutrient Content in the Breast Milk and Blood of Women During Breastfeeding Period and on Babies' Physical Growth Parameters</brief_title>
  <official_title>Effects of Multiple Micronutrients, Lutein and Docosahexaenoic Acid (DHA) Supplementation During Lactation on Human Milk Nutrient Content, Maternal Blood Biomarkers and Infant Anthropometric Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA&#xD;
      supplementation (Elevit Breastfeeding &amp; Postnatal Care) on the breast milk nutrient&#xD;
      composition and babies physical growth parameters.&#xD;
&#xD;
      Mothers participating in this study received either Elevit or placebo orally once a day for&#xD;
      12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were&#xD;
      collected from the mothers and physical parameters like size and weight were collected from&#xD;
      the babies to assess the effect of the supplementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2017</start_date>
  <completion_date type="Actual">November 12, 2019</completion_date>
  <primary_completion_date type="Actual">November 12, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
    <description>The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood parameters: % concentration relative to total milk</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
    <description>Fatty acids (FA) in plasma and glycerophospholipids (GPL); DHA/total fatty acid (TFA) ratio; IFN-gamma; TGF-beta; Folic acid, Vitamin B12 and homocystein; 25-Hydroxivitamin D; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in milk parameters: % concentration relative to total milk</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
    <description>Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: maternal height</measure>
    <time_frame>At Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: maternal weight</measure>
    <time_frame>At Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Maternal BMI kg/m2</measure>
    <time_frame>At Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Maternal fatigue questionnaire</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Maternal food frequancy questionnaire</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Infant weight</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Infant length</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)</measure>
    <time_frame>At Baseline and 6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events (AEs)</measure>
    <time_frame>Up to 13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs</measure>
    <time_frame>Up to 13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE relationship to the investigational product</measure>
    <time_frame>Up to 13 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Healthy Lactating Mother</condition>
  <arm_group>
    <arm_group_label>Healthy lactating women - Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy lactating women - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Elevit Breastfeeding &amp; Postnatal Care</intervention_name>
    <description>Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral</description>
    <arm_group_label>Healthy lactating women - Supplement</arm_group_label>
    <other_name>BAY987816 - Multi-micronutrients, lutein &amp; DHA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>No active ingredients except of 225 μg iodine; One capsule daily, oral</description>
    <arm_group_label>Healthy lactating women - Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for women:&#xD;
&#xD;
          -  Healthy pregnant women aged 18 to 45 years (inclusive) in their third trimester of&#xD;
             pregnancy who are expected to give birth to a healthy single full-term infant;&#xD;
&#xD;
          -  Hb &gt; 105 g/L;&#xD;
&#xD;
          -  Intention to breastfeed for at least four months (no more than one bottle or 10% of&#xD;
             total milk intake daily as formula);&#xD;
&#xD;
          -  Omnivorous diet;&#xD;
&#xD;
          -  Not intent to take multivitamin supplements, DHA supplements, lutein supplements or&#xD;
             any combination of the aforementioned after giving birth except for iodine and iron;&#xD;
&#xD;
          -  Seronegative for Human Immunodeficiency Virus (HIV), Hepatitis B, and Hepatitis C at&#xD;
             screening;&#xD;
&#xD;
          -  Pregnant women who, in the opinion of the Investigator, are willing and able to&#xD;
             participate in all scheduled visits, to adhere to the study plan, to laboratory tests&#xD;
             and to all other study related procedures according to the clinical protocol;&#xD;
&#xD;
          -  Pregnant women providing a personally signed and dated informed consent willing to&#xD;
             participate in the study and to adhere to all study procedures including the&#xD;
             assessments done to the infant, indicating that they have been informed of all&#xD;
             pertinent aspects of the trial and that they understood and accepted these, prior to&#xD;
             admission to the study.&#xD;
&#xD;
        Inclusion Criteria for infants:&#xD;
&#xD;
          -  Full term/gestational age &gt; 37 weeks &lt; 43 weeks and birth weight adequate for&#xD;
             gestational age;&#xD;
&#xD;
          -  Apgar score at 5 minutes after birth &gt; 7;&#xD;
&#xD;
          -  No indication of abnormal neurodevelopment.&#xD;
&#xD;
        Exclusion Criteria for women:&#xD;
&#xD;
          -  Physical (including vital signs e.g. blood pressure, pulse rate), hematological and&#xD;
             clinical-chemical parameters deviating from normal and with clinical relevance in the&#xD;
             opinion of the investigator;&#xD;
&#xD;
          -  Any serious infection (acute or chronic) at screening and randomization;&#xD;
&#xD;
          -  Any history of or current metabolic diseases (e.g. diabetes, hypothyroidism, and other&#xD;
             metabolic diseases);&#xD;
&#xD;
          -  Less than 12 months from previous delivery;&#xD;
&#xD;
          -  Any history of or current diseases, which are associated with malabsorption, or other&#xD;
             severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel&#xD;
             disease, iron accumulation, iron utilization disorders);&#xD;
&#xD;
          -  Any history of or current neurological, cardiac, endocrine or bleeding disorders;&#xD;
&#xD;
          -  Specific diets (e.g. vegan, vegetarian, celiac);&#xD;
&#xD;
          -  Pre-pregnancy body mass index (BMI) &lt; 18.5 or &gt; 30 kg/m2;&#xD;
&#xD;
          -  Diagnosed or suspected malignant or premalignant disease;&#xD;
&#xD;
          -  Current clinically significant depression;&#xD;
&#xD;
          -  Not willing, or unable for medical reasons to interrupt any intake of pharmaceuticals&#xD;
             or dietary supplements which may interact with any of the ingredients of the trial&#xD;
             product (i.e. fluoroquinolones, bisphosphonates, levodopa, levothyroxine,&#xD;
             penicillamine, antibiotics containing tetracycline or trietine) during the study&#xD;
             supplementation period (From Visit 2 (Randomization) until Visit 4 (EoS));&#xD;
&#xD;
          -  History of or current diseases where vitamin, mineral, trace element, lutein or DHA&#xD;
             supplementation might be not recommended / contraindicated (such as sickle cell&#xD;
             anemia, copper metabolism disorders (Wilson's disease), renal disease,&#xD;
             nephrolithiasis, urolithiasis, hypercalcemia, hypercalciuria, hepatobiliary diseases,&#xD;
             existing hypervitaminosis, iron metabolism disorders, hypermagnesemia);&#xD;
&#xD;
          -  Any pregnancy complications or adverse pregnancy outcomes in current pregnancy that&#xD;
             may affect micronutrient metabolism or status (e.g. preeclampsia, eclampsia,&#xD;
             polyhydramniosis, placental insufficiency);&#xD;
&#xD;
          -  Diagnosed congenital abnormalities in current pregnancy;&#xD;
&#xD;
          -  Current smoker or smoker during current pregnancy.&#xD;
&#xD;
        Main exclusion criteria for infants:&#xD;
&#xD;
          -  Congenital anomalies;&#xD;
&#xD;
          -  Obvious gastrointestinal or metabolic disorders;&#xD;
&#xD;
          -  Perinatal hypoxia;&#xD;
&#xD;
          -  Preterm birth;&#xD;
&#xD;
          -  Very low birth weight (VLBW).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynäkologische Gemeinschaftspraxis Freising</name>
      <address>
        <city>Freising</city>
        <state>Bayern</state>
        <zip>85354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Hr. E. Goeckeler-Leopold</name>
      <address>
        <city>Geseke</city>
        <state>Nordrhein-Westfalen</state>
        <zip>59590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Fr. Dr. K. Maar</name>
      <address>
        <city>Berlin</city>
        <zip>13507</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04462939
org study id: 18737
nct id: NCT04462939
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA
      supplementation (Elevit Breastfeeding & Postnatal Care) on the breast milk nutrient
      composition and babies physical growth parameters.

      Mothers participating in this study received either Elevit or placebo orally once a day for
      12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were
      collected from the mothers and physical parameters like size and weight were collected from
      the babies to assess the effect of the supplementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk
time frame: At Baseline and 6 weeks and 12 weeks
description: The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
measure: Change from baseline in blood parameters: % concentration relative to total milk
time frame: At Baseline and 6 weeks and 12 weeks
description: Fatty acids (FA) in plasma and glycerophospholipids (GPL); DHA/total fatty acid (TFA) ratio; IFN-gamma; TGF-beta; Folic acid, Vitamin B12 and homocystein; 25-Hydroxivitamin D; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
measure: Change from baseline in milk parameters: % concentration relative to total milk
time frame: At Baseline and 6 weeks and 12 weeks
description: Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
measure: Change from baseline: maternal height
time frame: At Baseline and 12 weeks
measure: Change from baseline: maternal weight
time frame: At Baseline and 12 weeks
measure: Change from baseline: Maternal BMI kg/m2
time frame: At Baseline and 12 weeks
measure: Change from baseline: Maternal fatigue questionnaire
time frame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Maternal food frequancy questionnaire
time frame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant weight
time frame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant length
time frame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
time frame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
time frame: At Baseline and 6 weeks and 12 weeks
measure: Number of Adverse Events (AEs)
time frame: Up to 13 weeks
measure: Severity of AEs
time frame: Up to 13 weeks
measure: AE relationship to the investigational product
time frame: Up to 13 weeks
arm group label: Healthy lactating women - Supplement
arm group type: Experimental
description: At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks.
arm group label: Healthy lactating women - Placebo
arm group type: Placebo Comparator
description: At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks.
intervention type: Dietary Supplement
intervention name: Elevit Breastfeeding & Postnatal Care
description: Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
arm group label: Healthy lactating women - Supplement
other name: BAY987816 - Multi-micronutrients, lutein & DHA
intervention type: Drug
intervention name: Placebo
description: No active ingredients except of 225 μg iodine; One capsule daily, oral
arm group label: Healthy lactating women - Placebo
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Micronutrients