Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Birth Outcomes and Growth in Southern Nepal
Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Birth Outcomes and Growth in Southern Nepal
NCT ID: NCT03668977 Phase: NA Status: COMPLETED Enrollment: 1944 Completion: 2024-09-30
Conditions
Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition
Interventions
Fortified balanced protein-energy.
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.
Primary Outcome
Small-for-Gestational-Age (<10th centile weight(g) for gestational age)