NCT04462939

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Lactating Mother

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elevit Breastfeeding & Postnatal Care	Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
DRUG	Placebo	No active ingredients except of 225 μg iodine; One capsule daily, oral

Timeline

• Start date: 2017-04-26
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2020-07-08
• Last updated: 2020-07-08

Locations

3 sites across 1 country: Germany