BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)

NCT05576207 | Active Not Recruiting

• 2 other identifiers: INV-033381IRB00021021
• Study Type: interventional
• Target: 3,390
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low prepregnancy BMI or low prepregnancy BMI and inadequate gestational weight gain) on birth weight and adverse birth outcomes of low birth weight (LBW \< 2500 g) and small-for-gestational age (SGA). To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms The main question\[s\] it aims to answer are:

1. 1.A daily BEP supplement from enrollment until birth
2. 2.A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement
3. 3.A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement or get switched to a BEP supplement based on inadequate gestational weight gain.

Conditions

Fetal Growth Retardation; Low Birth Weight; Preterm Birth; Gestational Weight Gain; Stunting; Anemia of Pregnancy; Pregnancy Complications

Keywords

Pregnancy; Birth weight; Energy and protein; Micronutrients; Antenatal care; Nutrition; Birth outcomes

Outcome Measures

Primary Outcomes (3)

• Birth weight

  Birth weight

  Weight taken within 0-72 hours of birth

• Low birth weight (weight < 2500 g) at birth

  Dichotomous representation of the primary outcome

  Weight taken within 0-72 hours of birth

• Small-for-gestational age

  Weight for a given gestational age lower than the 10th percentile of the reference standard

  Measured within 0-72 hours of birth

Secondary Outcomes (6)

• Birth length

  Measured within 0-72 hours of birth

• Gestational weight change

  weight from pre-pregnancy to weight measured at birth

• Proportion of inadequate gestational weight gain

  From pre-pregnancy to birth

• Head circumference at birth

  at birth

• Chest circumference at birth

  at birth

Other Outcomes (11)

• Length-for-age Z score at birth

  At Birth

• weight-for-length Z score at birth

  At Birth

• Stunting at birth

  At birth

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Multiple Micronutrient Supplement for Pregnant women (UNIMMAP formulation) containing 15 nutrients all at a recommended daily allowance (RDA) for pregnancy to be consumed one-per-day during pregnancy

Dietary Supplement: Multiple Micronutrient Supplement for pregnant women

Arm 2

EXPERIMENTAL

Balanced energy and protein (BEP) food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the World Health Organization (WHO) for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm all pregnant women will receive this intervention

Dietary Supplement: Balanced energy and protein supplement for pregnant women

Arm 3

EXPERIMENTAL

Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (\<18.5) will receive the BEP, the rest will receive the MMS.

Dietary Supplement: Balanced energy and protein supplement for pregnant women

Arm 4

EXPERIMENTAL

Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (\<18.5) and those who have inadequate gestational weight gain during pregnancy will receive the BEP, the rest will receive the MMS.

Dietary Supplement: Balanced energy and protein supplement for pregnant women

Interventions

Balanced energy and protein supplement for pregnant women DIETARY_SUPPLEMENT

A fortified balanced energy and protein supplement providing both macro and micronutrients recommended for use during pregnancy in undernourished contexts.

Also known as: BEP

Arm 2; Arm 3; Arm 4

Multiple Micronutrient Supplement for pregnant women DIETARY_SUPPLEMENT

Prenatal supplements containing vitamins and minerals - also called "multiple micronutrient" supplements will be used in the control group.

Also known as: MMS

Arm 1

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Married women of reproductive age (15-35 y)
• living in the selected study area who are pregnant and consent to participate in the study.

You may not qualify if:

• Currently pregnant or lactating women (through 12 months postpartum),
• Married women who are sterilized or widowed/divorced will not be included in the pregnancy surveillance being used to identify newly pregnant women.
• Women with gestational age of \>=28 weeks of gestation using reported last menstrual period.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator
• BRAC James P Grant School of Public Health, BRAC University: collaborator

Study Sites (1)

JiVitA Project

Rangpur City, Bangladesh

Location

Related Publications (1)

• Zavala E, Mohan D, Ali H, Siddiqua TJ, Haque R, Ayesha K, Ahsan KB, Sujan HM, Khaled N, Rahman A, Chakraborty B, Dyer B, Wu LSF, Kalbarczyk A, Erchick DJ, Thorne-Lyman AL, Tumilowicz A, Afsana K, Christian P. Targeting strategies for balanced energy and protein (BEP) supplementation in pregnancy: study protocol for the TARGET-BEP cluster-randomized controlled trial in rural Bangladesh. Trials. 2024 May 13;25(1):315. doi: 10.1186/s13063-024-08135-4.

  PMID: 38741174 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation; Premature Birth; Gestational Weight Gain; Growth Disorders; Pregnancy Complications; Birth Weight

Condition Hierarchy (Ancestors)

Fetal Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms

Study Officials

• Parul Christian, DrPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: October 15, 2022
• Primary Completion: April 23, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

BA (1)