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
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