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

Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant Mortality; Vitamin A Deficiency

Intervention: vitamin A supplementation (50,000 IU) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Rolf DW Klemm, Dr PH, Principal Investigator, Affiliation: Johns Hopkins University
Keith P West, Jr., Dr. P.H., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health
Parul Christian, Dr. P.H., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health
Mahbubar Rashid, MBBS, MSc, MBA, Study Director, Affiliation: JiVitA Bangladesh Project
Alain B. Labrique, MSc, Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health
Alfred Sommer, M.D., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: 24-week infant mortality rate

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.

Eligibility

Minimum age: N/A. Maximum age: 30 Days. Gender(s): Both.

Criteria:

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

Locations and Contacts

JiVitA Bangladesh Project, Rangpur, Rajshahi Division, Bangladesh
Additional Information

Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health)

Starting date: January 2004
Last updated: April 9, 2007

Page last updated: August 20, 2015

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