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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mortality Through Six Months of Age, Vitamin A Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Supplement containing soybean oil with a small amount of vitamin E as an antioxidant | Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)<br>* Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo<br>|
| Active Comparator: Vitamin A<br>15,000 ug retinol equivalents (50,000 International Units) | Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)<br>* Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-week infant mortality rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin A, Newborn health, Infant Mortality, Supplementation, Micronutrients, Bangladesh