The overall goal of the trial is to provide critical evidence to help resolve the controversy on the survival benefit of supplementing young infants with vitamin A. The primary aim of the study is to 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.

Condition	Intervention	Phase
Mortality	Drug: vitamin A supplementation (50,000 IU)	Phase III

Further Study Details: 

Primary Outcomes: 6-month infant mortality rate
Expected Total Enrollment:  25000

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.

Ages Eligible for Study:  up to  30 Days,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Exclusion Criteria:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00128557

Rolf DW Klemm, DrPH      410-614-2848    rklemm@jhsph.edu
Keith P. West, Jr., DrPH      410-955-2061    kwest@jhsph.edu

Bangladesh
      Gaibanda/Rangpur District, Gaibandha,  Bangladesh; Recruiting

Study chairs or principal investigators

Rolf DW Klemm, Dr PH,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  H.22.03.01.09.A2
Last Updated:  August 9, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00128557
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23