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Micronutrient Dose Response Study in Bangladesh

NCT06081114 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2025-10-01

No results posted yet for this study

Summary

The recommended daily amounts of vitamins and minerals, referred to as micronutrients, are based on data from high income settings and for healthy populations do not fully correct nutritional deficiencies in undernourished settings. This study will determine the minimum acceptable doses across a range of nutrients at which sufficiency is achieved with supplementation using biochemical indicators of nutritional status in non-pregnant (non-lactating) women of reproductive age and pregnant women in Bangladesh. In this double-masked randomized controlled trial, a dose response study will be undertaken using increasing levels of doses provided as supplements to women (pregnant or non-pregnant) with nutritional indicators as outcomes.

Conditions

  • Micronutrient Status

Interventions

DIETARY_SUPPLEMENT

Micronutrient Supplement

A packaged food supplement providing calories and protein and fortified with micronutrients provided at an approximate RDA.

Sponsors & Collaborators

  • International Center for Diarrheal Disease Research, Bangladesh (icddr,b)

    collaborator UNKNOWN

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Parul Chrisian, DrPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-22
Primary Completion
2025-09-22
Completion
2026-09-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081114 on ClinicalTrials.gov