Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
September 28, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15937
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajshahi Division
-
Rangpur, Rajshahi Division, Bangladesh
- JiVitA Bangladesh Project
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Supplement containing soybean oil with a small amount of vitamin E as an antioxidant
|
Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo
|
|
Active Comparator: Vitamin A
15,000 ug retinol equivalents (50,000 International Units)
|
Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
24-week infant mortality rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rolf DW Klemm, Dr PH, Johns Hopkins University
- Study Director: Keith P West, Jr., Dr. P.H., Johns Hopkins Bloomberg School of Public Health
- Study Director: Parul Christian, Dr. P.H., Johns Hopkins Bloomberg School of Public Health
- Study Director: Mahbubar Rashid, MBBS, MSc, MBA, JiVitA Bangladesh Project
- Study Director: Alain B. Labrique, MSc, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.
- Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
August 9, 2005
First Submitted That Met QC Criteria
August 9, 2005
First Posted (Estimate)
August 10, 2005
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H.22.03.01.09.A2
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