Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Canadian International Development Agency
The Sight and Life Research Institute
Access Business Group
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198822
First received: September 12, 2005
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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
Vitamin A Deficiency
Maternal Mortality
Infant Mortality
Dietary Supplement: Vitamin A or Beta-Carotene Supplements
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

Resource links provided by NLM:


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

Primary Outcome Measures:
  • All-cause, Pregnancy-related Mortality [ Time Frame: Deaths during pregnancy through 12 weeks postpartum ] [ Designated as safety issue: No ]
    Mortality evaluated on intent-to-treat basis


Secondary Outcome Measures:
  • All-cause 3-month Infant Mortality [ Time Frame: Deaths through the 1st 12 weeks of life ] [ Designated as safety issue: No ]
  • Maternal Morbidity, Including Obstetric Complications [ Time Frame: through the 1st 24 weeks following termination of pregnancy ] [ Designated as safety issue: No ]
  • Gestational Age at Birth [ Time Frame: within 24 weeks after birth ] [ Designated as safety issue: No ]
  • Fetal Growth and Postnatal Infant Growth Through Three Months of Age [ Time Frame: through the 1st 12 weeks after birth ] [ Designated as safety issue: No ]
  • Infant Morbidity Through 3 Months of Age [ Time Frame: within 24 weeks after birth ] [ Designated as safety issue: No ]
  • Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother) [ Time Frame: Third trimester of pregnancy (about the 32nd week of gesatation) ] [ Designated as safety issue: No ]
  • Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother) [ Time Frame: Third trimester of pregnancy (about the 32nd week of gestation) ] [ Designated as safety issue: No ]

Enrollment: 59666
Study Start Date: August 2001
Study Completion Date: March 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
Dietary Supplement: Vitamin A or Beta-Carotene Supplements
weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
Experimental: 2
Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Dietary Supplement: Vitamin A or Beta-Carotene Supplements
weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
Placebo Comparator: 3
Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
Dietary Supplement: Vitamin A or Beta-Carotene Supplements
weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy

Detailed 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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Married women of reproductive age
  • First pregnancy during time period of trial

Exclusion Criteria:

  • Premenarchial girls
  • Married women with a previous pregnancy enrolled into the trial
  • Previously married women who have moved into the study area
  • Single women (never married, widowers)
  • Women who are sterilized (or whose husbands are sterilized)
  • Menopausal women
  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: NCT00198822

Locations
United States, Maryland
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
Bangladesh
JiVitA Bangladesh Project
Rangpur, Rajshahi Division, Bangladesh
JiVitA Project Office
Rangpur, Rangpur District, Bangladesh, 5400
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Canadian International Development Agency
The Sight and Life Research Institute
Access Business Group
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith P. West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198822     History of Changes
Other Study ID Numbers: GHS-A-00-03-00019-00
Study First Received: September 12, 2005
Results First Received: September 1, 2011
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board
Bangladesh: Bangladesh Medical Research Council

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Maternal mortality
Infant mortality
Vitamin A
Beta-carotene
Micronutrients
Bangladesh
Neonatal mortality

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Maternal Death
Pregnancy Complications
Parental Death
Death
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Beta Carotene
Retinol palmitate
Carotenoids
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 September 30, 2014