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Trial of the Impact of Vitamin A on Maternal Mortality

NCT00211341 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2010-02-18

No results posted yet for this study

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

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.

Conditions

  • Vitamin A Deficiency
  • Maternal Mortality
  • Maternal Morbidity

Interventions

DIETARY_SUPPLEMENT

Vitamin A

Weekly single oral dose 7000 micrograms

Sponsors & Collaborators

  • Kintampo Health Research Centre, Ghana

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Betty R Kirkwood · London School of Hygiene and Tropical Medicine

  • Oona Campbell · London School of Hygiene and Tropical Medicine

  • Seth Owusu-Agyei · Kintampo Health Research Centre, Ghana

  • Guus Ten Asbroek · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211341 on ClinicalTrials.gov