At a glance
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Impact of a Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Reproductive Outcomes and Growth in Southern Nepal
In Brief
A clinical study evaluating Fortified balanced protein-energy. for Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition. Completed, enrolled 1,944 participants across 1 site.
Detailed Summary
This project will test the efficacy of a balanced protein energy supplement for daily use during pregnancy and the first 6 months after delivery on the outcomes of pregnancy and growth of infants during the first 6 months of life. Approximately 1800 pregnant women from a district in southern Nepal will be recruited and randomly assigned to one of 4 groups, control in pregnancy \& post-partum, supplementation in pregnancy \& control post-partum, control in pregnancy \& supplementation post-partum, or supplementation in pregnancy \& post-partum. Pregnancies will be followed until delivery and the infants through 6 months of age. Outcomes of interest include birth size (weight and length), gestational age at delivery, maternal weight gain in pregnancy, maternal weight at 6 months post-partum, infant growth, and breast milk composition.
Study Details
Timeline
Interventions
The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B\&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). The calorie content will be approxmately 400 Kcal/day with approximately 14 g of protein.