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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00198822
Other study ID # GHS-A-00-03-00019-00
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated March 5, 2012
Start date August 2001
Est. completion date March 2008

Study information

Verified date March 2012
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardBangladesh: Bangladesh Medical Research Council
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59666
Est. completion date March 2008
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility 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

Study Design

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


Intervention

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

Locations

Country Name City State
Bangladesh JiVitA Bangladesh Project Rangpur Rajshahi Division
Bangladesh JiVitA Project Office Rangpur Rangpur District
United States Johns Hopkins School of Public Health Baltimore Maryland

Sponsors (6)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Access Business Group, Bill and Melinda Gates Foundation, Canadian International Development Agency, The Sight and Life Research Institute, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

United States,  Bangladesh, 

References & Publications (9)

Christian P, West KP Jr, Khatry SK, Katz J, LeClerq SC, Kimbrough-Pradhan E, Dali SM, Shrestha SR. Vitamin A or beta-carotene supplementation reduces symptoms of illness in pregnant and lactating Nepali women. J Nutr. 2000 Nov;130(11):2675-82. — View Citation

Christian P, West KP Jr, Khatry SK, Kimbrough-Pradhan E, LeClerq SC, Katz J, Shrestha SR, Dali SM, Sommer A. Night blindness during pregnancy and subsequent mortality among women in Nepal: effects of vitamin A and beta-carotene supplementation. Am J Epidemiol. 2000 Sep 15;152(6):542-7. — View Citation

Christian P, West KP Jr, Khatry SK, LeClerq SC, Kimbrough-Pradhan E, Katz J, Shrestha SR. Maternal night blindness increases risk of mortality in the first 6 months of life among infants in Nepal. J Nutr. 2001 May;131(5):1510-2. — View Citation

Gunnsteinsson S, Labrique AB, West KP Jr, Christian P, Mehra S, Shamim AA, Rashid M, Katz J, Klemm RD. Constructing indices of rural living standards in Northwestern Bangladesh. J Health Popul Nutr. 2010 Oct;28(5):509-19. — View Citation

Katz J, West KP Jr, Khatry SK, Pradhan EK, LeClerq SC, Christian P, Wu LS, Adhikari RK, Shrestha SR, Sommer A. Maternal low-dose vitamin A or beta-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal. Am J Clin Nutr. 2000 Jun;71(6):1570-6. — View Citation

Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21 — View Citation

West KP Jr, Christian P, Labrique AB, Rashid M, Shamim AA, Klemm RD, Massie AB, Mehra S, Schulze KJ, Ali H, Ullah B, Wu LS, Katz J, Banu H, Akhter HH, Sommer A. Effects of vitamin A or beta carotene supplementation on pregnancy-related mortality and infan — View Citation

West KP Jr, Katz J, Khatry SK, LeClerq SC, Pradhan EK, Shrestha SR, Connor PB, Dali SM, Christian P, Pokhrel RP, Sommer A. Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group. BMJ. 1999 Feb 27;318(7183):570-5. — View Citation

West KP Jr. Extent of vitamin A deficiency among preschool children and women of reproductive age. J Nutr. 2002 Sep;132(9 Suppl):2857S-2866S. Erratum in: J Nutr 2002 Nov;132(11):3432. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause, Pregnancy-related Mortality Mortality evaluated on intent-to-treat basis Deaths during pregnancy through 12 weeks postpartum No
Secondary All-cause 3-month Infant Mortality Deaths through the 1st 12 weeks of life No
Secondary Maternal Morbidity, Including Obstetric Complications through the 1st 24 weeks following termination of pregnancy No
Secondary Gestational Age at Birth within 24 weeks after birth No
Secondary Fetal Growth and Postnatal Infant Growth Through Three Months of Age through the 1st 12 weeks after birth No
Secondary Infant Morbidity Through 3 Months of Age within 24 weeks after birth No
Secondary Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother) Third trimester of pregnancy (about the 32nd week of gesatation) No
Secondary Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother) Third trimester of pregnancy (about the 32nd week of gestation) No
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