Different Doses of Vitamin A and Childhood 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
Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio
vaccine in national campaigns. However, it is not clear which dose is optimal. The two
studies that have investigated the impact of different doses of vitamin A have both found
that a smaller dose was better than a large dose. We therefore investigated if a smaller
dose given with oral polio vaccine gives equal or better effect.
Clinical Details
Official title: Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: MortalityHospitalisations Morbidity Growth
Secondary outcome: Rotavirus infection
Detailed description:
Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause
mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination
contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU
for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older.
There is no clear evidence that a large dose is better than a small dose, the tendency being
the opposite in the two studies of different doses of VAS that have been published so far.
With the global effort to eradicate polio, national immunization days with oral polio
vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a
combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the
best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by
WHO or half this dose gives a better protection against childhood morbidity and mortality.
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: Between 6 mo and 5 years old and thus eligible for OPV and vitamin A
during national immunisation day
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Exclusion Criteria: Children with overt signs of vitamin A deficiency will not be enrolled
in the study, but treated according to the recommendations. -
Locations and Contacts
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau
Additional Information
Starting date: November 2002
Last updated: September 12, 2005
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