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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health United States Agency for International Development (USAID) Bill and Melinda Gates Foundation The Canadian International Development Agency The Sight and Life Research Institute Access Business Group |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00198822 |
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.
Condition | Intervention | Phase |
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Vitamin A Deficiency |
Drug: Vitamin A or Beta-Carotene Supplements |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh |
Estimated Enrollment: | 68000 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | May 2007 |
Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. The present trial is testing the efficacy of the same supplements from ~9 weeks' gestation to 12 weeks postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19 rural unions, covering an area of ~750 sq km with a population of ~580,000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; ~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. Newly married women are prospectively enlisted for pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are recorded weekly through 3 months postpartum. Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. At 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. An additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. A ~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.
Ages Eligible for Study: | 15 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keith P West, Jr., Dr.P.H. | 410-955-2061 | kwest@jhsph.edu |
Contact: Parul Christian, Dr.P.H. | 410-955-1188 | pchristi@jhsph.edu |
Bangladesh, Rajshahi Division | |
JiVitA Bangladesh Project | Recruiting |
Rangpur, Rajshahi Division, Bangladesh | |
Contact: Alain B Labrique, MSc 880-521-63391 alabriqu@jhsph.edu | |
Contact: Keith P West, Jr., Dr.P.H. 410-955-2061 kwest@jhsph.edu | |
Sub-Investigator: Joanne Katz, Sc.D. | |
Sub-Investigator: Ahmed Shamim, M.Sc. | |
Sub-Investigator: Emorn Wasantwisut, Ph.D. |
Principal Investigator: | 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: | Rolf DW Klemm, Dr.P.H. | Johns Hopkins Bloomberg School of Public Health |
Study Director: | Mahbubur Rashid, MBBS, MSc | 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 |
Study ID Numbers: | GHS-A-00-03-00019-00 |
Study First Received: | September 12, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00198822 |
Health Authority: | United States: Institutional Review Board; Bangladesh: National Integrated Program in Health and Population, Ministry of Health and Family Welfare |
Maternal mortality Infant mortality Vitamin A Beta-carotene |
Micronutrients Bangladesh Perinatal mortality Neonatal mortality |
Vitamin A Deficiency Night Blindness Beta Carotene Vision Disorders Keratomalacia Avitaminosis Eye Diseases |
Blindness Malnutrition Retinol palmitate Vitamin A Nutrition Disorders Carotenoids Deficiency Diseases |
Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |