Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

October 18, 2022 updated by: Johns Hopkins Bloomberg School of Public Health

Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh

The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.

Study Type

Interventional

Enrollment (Actual)

44567

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Gaibandha District
      • Rangpur, Gaibandha District, Bangladesh
        • JiVitA Project Office
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant and consents to participate

Exclusion Criteria:

  • Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Iron (27 mg) and folic acid (600 ug)
Dietary supplement: Iron (27 mg) - folic acid (600 ug)
Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Other Names:
  • iron-folate
EXPERIMENTAL: 2
Multiple micronutrient
Dietary supplement: Multiple micronutrient

Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).

Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Other Names:
  • one-a-day multivitamin
  • antenatal micronutrient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Mortality Through 6 mo of Age
Time Frame: 6-months post-birth
Infant Mortality to Age 6 months (180 days from birth)
6-months post-birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Mortality
Time Frame: 1 month post-birth
Neonatal Mortality (28 days of life)
1 month post-birth
Post-neonatal Mortality
Time Frame: 1-6 months post-birth
Risk of Post-neonatal Mortality (29th -180th day of life)
1-6 months post-birth
Still Birth Rates
Time Frame: 24 weeks gestation to delivery
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
24 weeks gestation to delivery
Preterm Birth
Time Frame: Up to 37 weeks of gestation
Being born before 37 weeks of gestation
Up to 37 weeks of gestation
Extremely Pre-term
Time Frame: Up to 28 weeks of gestation
Birth before 28 weeks gestation
Up to 28 weeks of gestation
Very Pre-term
Time Frame: Between 27 and 33 weeks of gestation
Birth between 28 and 32 weeks of gestation
Between 27 and 33 weeks of gestation
Moderate to Late Preterm
Time Frame: Between 31 and 38 weeks of gestation
Birth between 32 and 37 weeks gestation
Between 31 and 38 weeks of gestation
Low Birth Weight
Time Frame: Measured at delivery/birth
Birth weight below 2500g
Measured at delivery/birth
Small for Gestation Age
Time Frame: At delivery/birth
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
At delivery/birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Johns Hopkins University
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Mahidol University
DSM Nutritional Products, Inc.
Beximco Pharmaceuticals Ltd.

Investigators

  • Principal Investigator: Keith P West, Jr., Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Parul Christian, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (ESTIMATE)

March 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHU_IRB 570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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