- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168636
Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality
The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Study Overview
Detailed Description
In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.
We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bissau, Guinea-Bissau
- Bandim Health Project, Apartado 861
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Between 6 mo and 5 years of age and thus eligible for vitamin A and OPV campaign -
Exclusion Criteria:Overt signs of vitamin A deficiency
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mortality
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Morbidity
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All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
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Secondary Outcome Measures
Outcome Measure |
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Growth
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Rota infection
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Measles infection
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Aaby, DMSc, Bandim Health Project
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91096-2dos04
- 91096-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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