Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality
Information source: Bandim Health Project
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mortality; Morbidity
Intervention: Vitamin A (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bandim Health Project Official(s) and/or principal investigator(s): Peter Aaby, DMSc, Principal Investigator, Affiliation: Bandim Health Project
Summary
We previously compared the effect on mortality of the half dose and the full dose currently
recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for
boys. The girls' response 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 a
new campaign, we will examine whether half the dose or 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.
Clinical Details
Official title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: MortalityMorbidity All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
Secondary outcome: Rota infectionMeasles infection Growth
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.
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
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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Locations and Contacts
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau
Additional Information
Starting date: November 2004
Last updated: November 14, 2013
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