Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 24-week infant mortality rate
| Estimated Enrollment: | 25000 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2006 |
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 |
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| Bangladesh | |
| JiVitA Bangladesh Project | |
| Rangpur, Rajshahi Division, Bangladesh | |
| 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:
|
Vitamin A Deficiency Night Blindness Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases Vitamin A Vitamins Retinol palmitate |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013