Trial record 3 of 21 for:
vitamin A | Interventional Studies | Bangladesh | Child
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
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| ClinicalTrials.gov Identifier: NCT00128557 |
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Recruitment Status :
Terminated
(Study terminated based on DSMB recommendation in December 2006)
First Posted : August 10, 2005
Last Update Posted : April 10, 2007
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Sponsor:
Johns Hopkins Bloomberg School of Public Health
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
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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 |
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 : | 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 |
| Actual Study Completion Date : | December 2006 |
Primary Outcome Measures :
- 24-week infant mortality rate
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 |
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
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
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 |
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.22.03.01.09.A2 |
| 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:
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Vitamin A Newborn health Infant Mortality |
Supplementation Micronutrients Bangladesh |
Additional relevant MeSH terms:
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Vitamin A Deficiency Vitamin A Retinol palmitate Night Blindness Infant Death Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases |
Death Pathologic Processes Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents |