A Phase 3 interventional study of vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU) in Mortality Through Six Months of Age and Vitamin A Deficiency, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Open to participants aged 1 Minute to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 15,937 is above the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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
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)
15,000 ug retinol equivalents (50,000 International Units)
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
24-week infant mortality rate
The record gives a start of Jan 2004, a primary completion of Dec 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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