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

NCT03668977 | Completed DMC

• 1 other identifier: 081739
• Study Type: interventional
• Target: 1,944
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Small-for-Gestational-Age (<10th centile weight(g) for gestational age)

  The incidence of SGA (\<10th centile) among live born infants whose birth weight(g) is measured within 72 hours of delivery. Comparison is between those supplemented during pregnancy versus those not.

  Within 72 hours of birth.

• Length-for-Age Z scores

  Mean Length(cm)-for-age Z score among infants at 6 months of age. Comparison is between women supplemented during post-partum period versus those not.

  6 months of age

Secondary Outcomes (18)

• Short-for-Gestational-Age (<10th centile height(cm) for gestational age)

  Within 72 hours of birth.

• Small-for-Gestational-Age (<3rd centile weight(g) for gestational age)

  Within 72 hours of birth.

• Short-for-Gestational-Age (<3rd centile height(cm) for gestational age)

  Within 72 hours of birth.

• Birth weight

  Within 72 hours of birth.

• Low birth weight (<2500 g)

  Within 72 hours of birth.

Study Arms (4)

Routine care

NO INTERVENTION

In all four groups, the following antenatal and post-natal interventions will be offered: * Women encouraged to enroll in routine antenatal care at their local health post/center. * A clean birthing kit consisting of a clean blade, string, and plastic disc for cutting the cord, a plastic sheet, a bar of soap, and a tube of chlorhexidine ointment for application to the umbilical stump. * Women encouraged to deliver at a certified birthing facility and participate in the government's incentive scheme. * Nutritional, hygiene, and infant care counseling. * Tetanus toxoid (if needed) and iron-folic acid supplements.

Supplementation-pregnancy

EXPERIMENTAL

A daily fortified balanced protein-energy nutritional supplement beginning in the 2nd trimester and continuing throughout pregnancy. 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 approximately 400 Kcal/day with approximately 14 g of protein.

Dietary Supplement: Fortified balanced protein-energy.

Supplementation-lactation

EXPERIMENTAL

A daily fortified balanced protein-energy nutritional supplement beginning after delivery and continuing through 6 months post-partum. 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 approximately 400 Kcal/day with approximately 14 g of protein.

Dietary Supplement: Fortified balanced protein-energy.

Supplementation-pregnancy & lactation

EXPERIMENTAL

A daily fortified balanced protein-energy nutritional supplement beginning in the 2nd trimester and continuing through 6 months post-partum. 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 approximately 400 Kcal/day with approximately 14 g of protein.

Dietary Supplement: Fortified balanced protein-energy.

Interventions

Fortified balanced protein-energy. DIETARY_SUPPLEMENT

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.

Supplementation-lactation; Supplementation-pregnancy; Supplementation-pregnancy & lactation

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all women who become pregnant during an approximate 6-month period in two cohorts in a set of Nagarpalikas and Gaunpalikas in Sarlahi District, Nepal.

You may not qualify if:

• Women who do not intend to deliver their child in the study area.
• Women who are allergic to milk, nuts or soy.
• Women who are unwilling to commit to daily consumption of the nutritional supplement if they are randomized to an active treatment arm.
• Women who refuse to provide consent.

Sponsors & Collaborators

• George Washington University: lead
• Harvard University: collaborator
• Johns Hopkins University: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Thrasher Research Fund: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Nepal Nutrition Intervention Project - Sarlahi

Hariaun, Sarlahi District, Nepal

Location

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Study Officials

• James M Tielsch, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Parul Christian, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Tsering P Lama, PhD

  Nepal Nutrition Intervention Project Sarlahi

  PRINCIPAL INVESTIGATOR

• Daniel Erchick, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair School of Public Health, PI

Model Details: 2 x 2 factorial design.

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: September 13, 2018
• Study Start: July 16, 2018
• Primary Completion: September 24, 2024
• Study Completion: September 30, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months following article publication. No end date.
• Access Criteria: Proposals should be directed to jtielsch@gwu.edu. To gain access, data requestors will need to sign a data access agreement. Data will be posted after 12 months to a website supported by the Bill and Melinda Gates Foundation.

Locations

NE (1)