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

Not Applicable

Completed

• Conditions: Healthy Lactating Mother
• Interventions: Dietary Supplement: Elevit Breastfeeding & Postnatal Care; Drug: Placebo

• Registration Number: NCT04462939
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-26
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Study First Submitted: 2020-05-29
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy lactating women - Supplement	Elevit Breastfeeding & Postnatal Care	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.
Healthy lactating women - Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline: Maternal BMI kg/m2	At Baseline and 12 weeks
Change from baseline: Maternal fatigue questionnaire	At Baseline and 6 weeks and 12 weeks
Change from baseline: Maternal food frequancy questionnaire	At Baseline and 6 weeks and 12 weeks
Change from baseline: maternal height	At Baseline and 12 weeks
Number of Adverse Events (AEs)	Up to 13 weeks
Change from baseline in blood parameters: % concentration relative to total milk	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)
Change from baseline in milk parameters: % concentration relative to total milk	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)
Change from baseline: maternal weight	At Baseline and 12 weeks
Severity of AEs	Up to 13 weeks
AE relationship to the investigational product	Up to 13 weeks
Change from baseline: Infant weight	At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant length	At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)	At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)	At Baseline and 6 weeks and 12 weeks

Trial Locations

Locations (3)

Praxis Fr. Dr. K. Maar; 🇩🇪 Berlin, Germany

Praxis Hr. E. Goeckeler-Leopold; 🇩🇪 Geseke, Nordrhein-Westfalen, Germany

Gynäkologische Gemeinschaftspraxis Freising; 🇩🇪 Freising, Bayern, Germany