Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128557
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2005-08-09
Brief Title:
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is determine whether a 50000 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:
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 ie villages andor smaller groupings in two thanas comprising a population of 580000 in rural northern Bangladesh GaibandhaRangpur 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None