Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

Phase 3

Completed

• Conditions: Mortality Through Six Months of Age; Vitamin A Deficiency
• Interventions: Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)

• Registration Number: NCT00128557
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

Detailed Description

This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of \~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-09
• Study First Submitted QC: 2005-08-09
• Study First Posted: 2005-08-10
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2007-04
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15937

Inclusion Criteria

Infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit

Exclusion Criteria

Infants who died before the dose could be administered or infants older than 30 days at the time of dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)	Supplement containing soybean oil with a small amount of vitamin E as an antioxidant
Vitamin A	vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)	15,000 ug retinol equivalents (50,000 International Units)

Primary Outcome Measures

Name	Time	Method
24-week infant mortality rate

Trial Locations

Locations (1)

JiVitA Bangladesh Project; 🇧🇩 Rangpur, Rajshahi Division, Bangladesh