Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00198822
Study type Interventional
Source Johns Hopkins Bloomberg School of Public Health
Contact
Status Completed
Phase Phase 3
Start date August 2001
Completion date March 2008

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03353662 - Sub Regional Micronutrient Survey in Ethiopia
Completed NCT01061307 - An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand Phase 0
Completed NCT00082420 - Retinol Equivalence of Plant Carotenoids in Children N/A
Completed NCT03383744 - Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon N/A
Recruiting NCT04438200 - Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults
Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Completed NCT02996513 - Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method N/A
Completed NCT02027610 - Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants N/A
Completed NCT02043223 - Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit Phase 2/Phase 3
Completed NCT01922713 - Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women N/A
Completed NCT05882682 - Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya
Completed NCT04632771 - Nutritional Status and Bouillon Use in Northern Ghana
Completed NCT02760095 - Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Active, not recruiting NCT01476358 - Effect of Vitamin A Supplementation on Immune Responses in Human Neonates Phase 2
Completed NCT04137354 - Iron and Vitamin A in School Children N/A
Completed NCT00198718 - Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates Phase 2
Not yet recruiting NCT04127968 - Efficacy and Safety of Vitamin A Treatment for Children With Sepsis N/A
Completed NCT03640104 - Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores N/A
Completed NCT01614483 - Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children N/A
Completed NCT02804490 - Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status Phase 3