NCT00128557

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15,937 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 1 Minute – 30 Days
• Healthy volunteers: Accepted

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.

Conditions

• Mortality Through Six Months of Age
• Vitamin A Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)	Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-08-10
• Last updated: 2022-10-03

Locations

1 site across 1 country: Bangladesh