Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Birth Outcomes and Growth in Southern Nepal

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.

Conditions

• Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition

Interventions

DIETARY_SUPPLEMENT

Fortified balanced protein-energy.

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.

Sponsors & Collaborators

• Harvard University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Thrasher Research Fund

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• George Washington University

  lead OTHER

Principal Investigators

• James M Tielsch, PhD · George Washington University

• Parul Christian, PhD · Johns Hopkins University

• Tsering P Lama, PhD · Nepal Nutrition Intervention Project Sarlahi

• Daniel Erchick, PhD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Max Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-16

Primary Completion

2024-09-24

Completion

2024-09-30

Countries

• Nepal

Study Locations