NCT00211341

Brief Summary

Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality. Hypotheses:

  1. 1.Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
  2. 2.This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
  3. 3.There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

7.8 years

First QC Date

September 13, 2005

Last Update Submit

February 17, 2010

Conditions

Vitamin A DeficiencyMaternal MortalityMaternal Morbidity

Keywords

PregnancyMortalityMaternalVitamin A

Outcome Measures

Primary Outcomes (1)

  • Pregnancy-related mortality and all cause mortality

    Continuous

Secondary Outcomes (3)

  • Severe maternal morbidity (based on Hospital admissions)

    Continuous

  • perinatal mortality

    Continuous

  • Infant mortality

    Continuous

Interventions

Vitamin ADIETARY_SUPPLEMENT

Weekly single oral dose 7000 micrograms

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All women of reproductive age (15 to 45 years) who are permanent residents in any of the 4 districts in rural Ghana (Kintampo, Wenchi, Techiman, and Nkoranza)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Brong Ahafo, PO Box 200, Ghana

Location

Related Publications (2)

  • Edmond K, Hurt L, Fenty J, Amenga-Etego S, Zandoh C, Hurt C, Danso S, Tawiah C, Hill Z, Ten Asbroek AH, Owusu-Agyei S, Campbell O, Kirkwood BR. Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial. BMJ Open. 2012 Jan 4;2(1):e000658. doi: 10.1136/bmjopen-2011-000658. Print 2012.

    PMID: 22218721DERIVED

  • Kirkwood BR, Hurt L, Amenga-Etego S, Tawiah C, Zandoh C, Danso S, Hurt C, Edmond K, Hill Z, Ten Asbroek G, Fenty J, Owusu-Agyei S, Campbell O, Arthur P; ObaapaVitA Trial Team. Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial. Lancet. 2010 May 8;375(9726):1640-9. doi: 10.1016/S0140-6736(10)60311-X.

    PMID: 20435345DERIVED

MeSH Terms

Conditions

Vitamin A DeficiencyMaternal 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

Study Officials

  • Betty R Kirkwood

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Oona Campbell

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Seth Owusu-Agyei

    Kintampo Health Research Centre, Ghana

    PRINCIPAL INVESTIGATOR

  • Guus Ten Asbroek

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2000

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 18, 2010

Record last verified: 2010-02

Locations

GH(1)