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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
68
Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
No active ingredients except of 225 μg iodine; One capsule daily, oral
Gynäkologische Gemeinschaftspraxis Freising
Freising, Bavaria, Germany
Praxis Hr. E. Goeckeler-Leopold
Geseke, North Rhine-Westphalia, Germany
Praxis Fr. Dr. K. Maar
Berlin, Germany
Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk
The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline in blood parameters: % concentration relative to total milk
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)
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline in milk parameters: % concentration relative to total milk
Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: maternal height
Time frame: At Baseline and 12 weeks
Change from baseline: maternal weight
Time frame: At Baseline and 12 weeks
Change from baseline: Maternal BMI kg/m2
Time frame: At Baseline and 12 weeks
Change from baseline: Maternal fatigue questionnaire
Time frame: 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
Change from baseline: Infant weight
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant length
Time frame: 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
Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
Time frame: At Baseline and 6 weeks and 12 weeks
Number of Adverse Events (AEs)
Time frame: Up to 13 weeks
Severity of AEs
Time frame: Up to 13 weeks
AE relationship to the investigational product
Time frame: Up to 13 weeks
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