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

July 6, 2020 updated by: Bayer

Effects of Multiple Micronutrients, Lutein and Docosahexaenoic Acid (DHA) Supplementation During Lactation on Human Milk Nutrient Content, Maternal Blood Biomarkers and Infant Anthropometric Parameters

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 13507
        • Praxis Fr. Dr. K. Maar
    • Bayern
      • Freising, Bayern, Germany, 85354
        • Gynäkologische Gemeinschaftspraxis Freising
    • Nordrhein-Westfalen
      • Geseke, Nordrhein-Westfalen, Germany, 59590
        • Praxis Hr. E. Goeckeler-Leopold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria for women:

  • Healthy pregnant women aged 18 to 45 years (inclusive) in their third trimester of pregnancy who are expected to give birth to a healthy single full-term infant;
  • Hb > 105 g/L;
  • Intention to breastfeed for at least four months (no more than one bottle or 10% of total milk intake daily as formula);
  • Omnivorous diet;
  • Not intent to take multivitamin supplements, DHA supplements, lutein supplements or any combination of the aforementioned after giving birth except for iodine and iron;
  • Seronegative for Human Immunodeficiency Virus (HIV), Hepatitis B, and Hepatitis C at screening;
  • Pregnant women who, in the opinion of the Investigator, are willing and able to participate in all scheduled visits, to adhere to the study plan, to laboratory tests and to all other study related procedures according to the clinical protocol;
  • Pregnant women providing a personally signed and dated informed consent willing to participate in the study and to adhere to all study procedures including the assessments done to the infant, indicating that they have been informed of all pertinent aspects of the trial and that they understood and accepted these, prior to admission to the study.

Inclusion Criteria for infants:

  • Full term/gestational age > 37 weeks < 43 weeks and birth weight adequate for gestational age;
  • Apgar score at 5 minutes after birth > 7;
  • No indication of abnormal neurodevelopment.

Exclusion Criteria for women:

  • Physical (including vital signs e.g. blood pressure, pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance in the opinion of the investigator;
  • Any serious infection (acute or chronic) at screening and randomization;
  • Any history of or current metabolic diseases (e.g. diabetes, hypothyroidism, and other metabolic diseases);
  • Less than 12 months from previous delivery;
  • Any history of or current diseases, which are associated with malabsorption, or other severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel disease, iron accumulation, iron utilization disorders);
  • Any history of or current neurological, cardiac, endocrine or bleeding disorders;
  • Specific diets (e.g. vegan, vegetarian, celiac);
  • Pre-pregnancy body mass index (BMI) < 18.5 or > 30 kg/m2;
  • Diagnosed or suspected malignant or premalignant disease;
  • Current clinically significant depression;
  • Not willing, or unable for medical reasons to interrupt any intake of pharmaceuticals or dietary supplements which may interact with any of the ingredients of the trial product (i.e. fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, antibiotics containing tetracycline or trietine) during the study supplementation period (From Visit 2 (Randomization) until Visit 4 (EoS));
  • History of or current diseases where vitamin, mineral, trace element, lutein or DHA supplementation might be not recommended / contraindicated (such as sickle cell anemia, copper metabolism disorders (Wilson's disease), renal disease, nephrolithiasis, urolithiasis, hypercalcemia, hypercalciuria, hepatobiliary diseases, existing hypervitaminosis, iron metabolism disorders, hypermagnesemia);
  • Any pregnancy complications or adverse pregnancy outcomes in current pregnancy that may affect micronutrient metabolism or status (e.g. preeclampsia, eclampsia, polyhydramniosis, placental insufficiency);
  • Diagnosed congenital abnormalities in current pregnancy;
  • Current smoker or smoker during current pregnancy.

Main exclusion criteria for infants:

  • Congenital anomalies;
  • Obvious gastrointestinal or metabolic disorders;
  • Perinatal hypoxia;
  • Preterm birth;
  • Very low birth weight (VLBW).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy lactating women - Supplement
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.
Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
Other Names:
  • BAY987816 - Multi-micronutrients, lutein & DHA
Placebo Comparator: Healthy lactating women - Placebo
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.
No active ingredients except of 225 μg iodine; One capsule daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
At Baseline and 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood parameters: % concentration relative to total milk
Time Frame: At Baseline and 6 weeks and 12 weeks
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)
At Baseline and 6 weeks and 12 weeks
Change from baseline in milk parameters: % concentration relative to total milk
Time Frame: At Baseline and 6 weeks and 12 weeks
Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
At Baseline and 6 weeks and 12 weeks
Change from baseline: maternal height
Time Frame: At Baseline and 12 weeks
At Baseline and 12 weeks
Change from baseline: maternal weight
Time Frame: At Baseline and 12 weeks
At Baseline and 12 weeks
Change from baseline: Maternal BMI kg/m2
Time Frame: At Baseline and 12 weeks
At Baseline and 12 weeks
Change from baseline: Maternal fatigue questionnaire
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Change from baseline: Maternal food frequancy questionnaire
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant weight
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant length
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
Time Frame: At Baseline and 6 weeks and 12 weeks
At Baseline and 6 weeks and 12 weeks
Number of Adverse Events (AEs)
Time Frame: Up to 13 weeks
Up to 13 weeks
Severity of AEs
Time Frame: Up to 13 weeks
Up to 13 weeks
AE relationship to the investigational product
Time Frame: Up to 13 weeks
Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

November 12, 2019

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18737

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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