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

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:

• Does mean birth weight and rate of LBW and SGA differ among mothers randomized to four arms that include targeted or untargeted BEP supplementation vs. MMS differ.

Participants will be recruited in early pregnancy and be enrolled in the trial and randomly receive:

1. A daily BEP supplement from enrollment until birth
2. A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement
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.

Researchers will compare the above groups to women receiving a MMS daily to see if birth weight is higher in the intervention arms. Other adverse outcomes such as low birth weight, small-for-gestational age and preterm birth will also be compared between groups and relative to the control.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Balanced energy and protein supplement for pregnant women

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

DIETARY_SUPPLEMENT

Multiple Micronutrient Supplement for pregnant women

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

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• BRAC James P Grant School of Public Health, BRAC University

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Parul Christian, DrPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-15

Primary Completion

2025-04-24

Completion

2025-05-29

Countries

• Bangladesh

Study Locations