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Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

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ClinicalTrials.gov Identifier: NCT00128557
Recruitment Status : Terminated (Study terminated based on DSMB recommendation in December 2006)
First Posted : August 10, 2005
Last Update Posted : April 10, 2007
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Infant Mortality Vitamin A Deficiency Drug: vitamin A supplementation (50,000 IU) Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Study Start Date : January 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 24-week infant mortality rate

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128557

JiVitA Bangladesh Project
Rangpur, Rajshahi Division, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
Johns Hopkins University
Bill and Melinda Gates Foundation
Canadian International Development Agency
Access Business Group
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
Study Director: Alfred Sommer, M.D. Johns Hopkins Bloomberg School of Public Health
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128557     History of Changes
Other Study ID Numbers: H.
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: April 10, 2007
Last Verified: April 2007

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Vitamin A
Newborn health
Infant Mortality

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Infant Death
Deficiency Diseases
Nutrition Disorders
Vision Disorders
Eye Diseases
Pathologic Processes
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents