NCT00198822

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59,666

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_3

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 12, 2011

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

5.4 years

First QC Date

September 12, 2005

Results QC Date

September 1, 2011

Last Update Submit

March 5, 2012

Conditions

Vitamin A DeficiencyMaternal MortalityInfant Mortality

Keywords

Maternal mortalityInfant mortalityVitamin ABeta-caroteneMicronutrientsBangladeshNeonatal mortality

Outcome Measures

Primary Outcomes (1)

  • All-cause, Pregnancy-related Mortality

    Mortality evaluated on intent-to-treat basis

    Deaths during pregnancy through 12 weeks postpartum

Secondary Outcomes (7)

  • All-cause 3-month Infant Mortality

    Deaths through the 1st 12 weeks of life

  • Maternal Morbidity, Including Obstetric Complications

    through the 1st 24 weeks following termination of pregnancy

  • Gestational Age at Birth

    within 24 weeks after birth

  • Fetal Growth and Postnatal Infant Growth Through Three Months of Age

    through the 1st 12 weeks after birth

  • Infant Morbidity Through 3 Months of Age

    within 24 weeks after birth

  • +2 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin A or Beta-Carotene Supplements

Interventions

Vitamin A or Beta-Carotene SupplementsDIETARY_SUPPLEMENT

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

123

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

JiVitA Bangladesh Project

Rangpur, Rajshahi Division, Bangladesh

Location

JiVitA Project Office

Rangpur City, Rangpur District, 5400, Bangladesh

Location

Related Publications (17)

  • 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.

    PMID: 10037634BACKGROUND

  • 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.

    PMID: 10837300BACKGROUND

  • 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.

    PMID: 11340108BACKGROUND

  • 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.

    PMID: 11053506BACKGROUND

  • 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.

    PMID: 10997544BACKGROUND

  • 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.

    PMID: 12221262BACKGROUND

  • 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.

    PMID: 21586714RESULT

  • 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.

    PMID: 21510905RESULT

  • 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.

    PMID: 20941903RESULT

  • 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.

    PMID: 28766094DERIVED

  • 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.

    PMID: 28490513DERIVED

  • 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.

    PMID: 27980605DERIVED

  • 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.

    PMID: 27449568DERIVED

  • 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.

    PMID: 25646326DERIVED

  • 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.

    PMID: 23151532DERIVED

  • 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.

    PMID: 22071710DERIVED

  • 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.

    PMID: 20977661DERIVED

Related Links

MeSH Terms

Conditions

Vitamin A DeficiencyMaternal DeathInfant Death

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesParental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Results Point of Contact

Title
Prof. Keith P West, Jr., Principal Investigator
Organization
Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health
kwest@jhsph.edu
410-955-2061

Study Officials

  • Keith P West, Jr., Dr.P.H.

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2001

Primary Completion

January 1, 2007

Study Completion

March 1, 2008

Last Updated

March 7, 2012

Results First Posted

October 12, 2011

Record last verified: 2012-03

Locations

BA(2)US(1)