Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity
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: Active, not recruiting
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 (VAS) is important for the immune system and may interact with
different childhood vaccinations. We have hypothesized that the improved survival after VAS
may depend on vitamin A amplifying the non-specific immune modulation induced by
vaccinations.
In the present study we used information collected in connection with a national vitamin A
campaign in Guinea-Bissau during which different doses of VAS was provided together with
missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential
interactions between VAS and vaccine type.
Clinical Details
Official title: Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: MortalityMorbidity Both outcomes analysed according to vaccine received and sex
Detailed description:
Vitamin A supplementation (VAS) acts as an adjuvant to vaccines, and VAS has been shown to
enhance both cellular and humoral immune responses in animals and in humans. Routine
childhood vaccinations have recently been shown to have important non-targeted effects on
mortality, i. e. effects that cannot be explained merely by the prevention of the targeted
disease. We have hypothesized that the improved survival after VAS may depend not only on
the prevention of vitamin A deficiency, but also on vitamin A amplifying the non-specific
immune modulation induced by routine vaccinations.
In the present study we used information collected in connection with a national vitamin A
campaign in Guinea-Bissau during which different doses of VAS was provided together with
missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential
interactions between VAS and vaccine type.
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: Between 6 months and 5 years and thus eligible for vitamin A and
missing vaccines during national immunisation days -
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 2003
Last updated: November 14, 2013
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