Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Mortality
- Sponsor
- Bandim Health Project
- Enrollment
- 6200
- Locations
- 1
- Primary Endpoint
- Mortality
- Last Updated
- 12 years ago
Overview
Brief 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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Mortality
Morbidity
Both outcomes analysed according to vaccine received and sex