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

Primary Purpose

Vitamin A Deficiency, Maternal Mortality, Infant Mortality

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vitamin A or Beta-Carotene Supplements
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin A Deficiency focused on measuring Maternal mortality, Infant mortality, Vitamin A, Beta-carotene, Micronutrients, Bangladesh, Neonatal mortality

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins School of Public Health
  • JiVitA Bangladesh Project
  • JiVitA Project Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy

Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy

Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy

Outcomes

Primary Outcome Measures

All-cause, Pregnancy-related Mortality
Mortality evaluated on intent-to-treat basis

Secondary Outcome Measures

All-cause 3-month Infant Mortality
Maternal Morbidity, Including Obstetric Complications
Gestational Age at Birth
Fetal Growth and Postnatal Infant Growth Through Three Months of Age
Infant Morbidity Through 3 Months of Age
Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)
Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)

Full Information

First Posted
September 12, 2005
Last Updated
March 5, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
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
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1. Study Identification

Unique Protocol Identification Number
NCT00198822
Brief Title
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Official Title
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency, Maternal Mortality, Infant Mortality
Keywords
Maternal mortality, Infant mortality, Vitamin A, Beta-carotene, Micronutrients, Bangladesh, Neonatal mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
Arm Title
2
Arm Type
Experimental
Arm Description
Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A or Beta-Carotene Supplements
Intervention Description
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
Primary Outcome Measure Information:
Title
All-cause, Pregnancy-related Mortality
Description
Mortality evaluated on intent-to-treat basis
Time Frame
Deaths during pregnancy through 12 weeks postpartum
Secondary Outcome Measure Information:
Title
All-cause 3-month Infant Mortality
Time Frame
Deaths through the 1st 12 weeks of life
Title
Maternal Morbidity, Including Obstetric Complications
Time Frame
through the 1st 24 weeks following termination of pregnancy
Title
Gestational Age at Birth
Time Frame
within 24 weeks after birth
Title
Fetal Growth and Postnatal Infant Growth Through Three Months of Age
Time Frame
through the 1st 12 weeks after birth
Title
Infant Morbidity Through 3 Months of Age
Time Frame
within 24 weeks after birth
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith P West, Jr., Dr.P.H.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Parul Christian, Dr.P.H.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rolf DW Klemm, Dr.P.H.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahbubur Rashid, MBBS, MSc
Organizational Affiliation
JiVitA Bangladesh Project
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alain B Labrique, MSc
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alfred Sommer, M.D.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
JiVitA Bangladesh Project
City
Rangpur
State/Province
Rajshahi Division
Country
Bangladesh
Facility Name
JiVitA Project Office
City
Rangpur
State/Province
Rangpur District
ZIP/Postal Code
5400
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
10037634
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. doi: 10.1136/bmj.318.7183.570.
Results Reference
background
PubMed Identifier
10837300
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. doi: 10.1093/ajcn/71.6.1570.
Results Reference
background
PubMed Identifier
11340108
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. doi: 10.1093/jn/131.5.1510.
Results Reference
background
PubMed Identifier
11053506
Citation
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. doi: 10.1093/jn/130.11.2675.
Results Reference
background
PubMed Identifier
10997544
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. doi: 10.1093/aje/152.6.542.
Results Reference
background
PubMed Identifier
12221262
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. doi: 10.1093/jn/132.9.2857S. Erratum In: J Nutr 2002 Nov;132(11):3432.
Results Reference
background
PubMed Identifier
21586714
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 infant mortality in rural Bangladesh: a cluster randomized trial. JAMA. 2011 May 18;305(19):1986-95. doi: 10.1001/jama.2011.656.
Results Reference
result
PubMed Identifier
21510905
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;12:102. doi: 10.1186/1745-6215-12-102.
Results Reference
result
PubMed Identifier
20941903
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. doi: 10.3329/jhpn.v28i5.6160.
Results Reference
result
PubMed Identifier
28766094
Citation
Surkan PJ, Sakyi KS, Christian P, Mehra S, Labrique A, Ali H, Ullah B, Wu L, Klemm R, Rashid M, West KP Jr, Strobino DM. Risk of Depressive Symptoms Associated with Morbidity in Postpartum Women in Rural Bangladesh. Matern Child Health J. 2017 Oct;21(10):1890-1900. doi: 10.1007/s10995-017-2299-7.
Results Reference
derived
PubMed Identifier
28490513
Citation
Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.
Results Reference
derived
PubMed Identifier
27980605
Citation
Sundaram ME, Ali H, Mehra S, Shamim AA, Ullah B, Rashid M, Shaikh S, Christian P, Klemm RD, West KP Jr, Labrique A. Early newborn ritual foods correlate with delayed breastfeeding initiation in rural Bangladesh. Int Breastfeed J. 2016 Dec 8;11:31. doi: 10.1186/s13006-016-0090-9. eCollection 2016.
Results Reference
derived
PubMed Identifier
27449568
Citation
Surkan PJ, Sakyi K, Strobino DM, Mehra S, Labrique A, Ali H, Ullah B, Wu L, Klemm R, Rashid M, West KP, Christian P. Depressive symptoms in mothers after perinatal and early infant loss in rural Bangladesh: a population-based study. Ann Epidemiol. 2016 Jul;26(7):467-473. doi: 10.1016/j.annepidem.2016.06.001. Epub 2016 Jun 8.
Results Reference
derived
PubMed Identifier
25646326
Citation
Shamim AA, Schulze K, Merrill RD, Kabir A, Christian P, Shaikh S, Wu L, Ali H, Labrique AB, Mehra S, Klemm RD, Rashid M, Sungpuag P, Udomkesmalee E, West KP Jr. First-trimester plasma tocopherols are associated with risk of miscarriage in rural Bangladesh. Am J Clin Nutr. 2015 Feb;101(2):294-301. doi: 10.3945/ajcn.114.094920. Epub 2014 Nov 26.
Results Reference
derived
PubMed Identifier
23151532
Citation
Christian P, Klemm R, Shamim AA, Ali H, Rashid M, Shaikh S, Wu L, Mehra S, Labrique A, Katz J, West KP Jr. Effects of vitamin A and beta-carotene supplementation on birth size and length of gestation in rural Bangladesh: a cluster-randomized trial. Am J Clin Nutr. 2013 Jan;97(1):188-94. doi: 10.3945/ajcn.112.042275. Epub 2012 Nov 14.
Results Reference
derived
PubMed Identifier
22071710
Citation
Christian P, Labrique AB, Ali H, Richman MJ, Wu L, Rashid M, West KP Jr. Maternal vitamin A and beta-carotene supplementation and risk of bacterial vaginosis: a randomized controlled trial in rural Bangladesh. Am J Clin Nutr. 2011 Dec;94(6):1643-9. doi: 10.3945/ajcn.111.019059. Epub 2011 Nov 9.
Results Reference
derived
PubMed Identifier
20977661
Citation
Shamim AA, Christian P, Schulze KJ, Ali H, Kabir A, Rashid M, Labrique A, Salamatullah Q, West KP Jr. Iodine status in pregnancy and household salt iodine content in rural Bangladesh. Matern Child Nutr. 2012 Apr;8(2):162-73. doi: 10.1111/j.1740-8709.2010.00282.x. Epub 2010 Oct 26.
Results Reference
derived
Links:
URL
http://www.jhsph.edu/chn/Research/micronutrients.html
Description
Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health

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

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