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Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)

NCT03921177 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9859

Last updated 2021-06-04

No results posted yet for this study

Summary

The purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy outcomes in rural Bangladesh.

Conditions

  • Birth Weight
  • Miscarriage
  • Small-for-gestational Age
  • Preterm Birth

Interventions

DIETARY_SUPPLEMENT

Multiple micronutrient supplement

Preconception to 12-weeks gestation: daily (coded) multiple micronutrient supplement containing 15-nutrients (vitamins and minerals) providing an approximate recommended dietary allowance for pregnant women, approximating the UNICEF UNIMAP formulation (UN micronutrient preparation).

DRUG

Placebo Oral Tablet

Preconception to 12-weeks gestation: identical tablet

Sponsors & Collaborators

  • JiVitA Project, Gaibandha, Bangladesh

    collaborator UNKNOWN

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Keith P West, Jr., DrPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2020-11-30
Completion
2021-05-29

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

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 NCT03921177 on ClinicalTrials.gov