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

This study has been terminated.
(Study terminated based on DSMB recommendation in December 2006)
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Johns Hopkins University
Bill and Melinda Gates Foundation
Canadian International Development Agency
Access Business Group
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00128557
First received: August 9, 2005
Last updated: April 9, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Infant Mortality
Vitamin A Deficiency
Drug: vitamin A supplementation (50,000 IU)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 24-week infant mortality rate

Estimated Enrollment: 25000
Study Start Date: January 2004
Study Completion Date: December 2006
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

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128557

Locations
Bangladesh
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
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
Study Director: Alfred Sommer, M.D. Johns Hopkins Bloomberg School of Public Health
  More Information

Additional Information:
No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128557     History of Changes
Other Study ID Numbers: H.22.03.01.09.A2
Study First Received: August 9, 2005
Last Updated: April 9, 2007
Health Authority: United States: Institutional Review Board
Bangladesh: National Integrated Program in Health and Population, Ministry of Health and Family Welfare

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

Additional relevant MeSH terms:
Night Blindness
Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
Eye Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Retinol palmitate
Vitamin A
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014