Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

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

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.

Official title: Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days

Study design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment

Primary outcome:

Mortality

Morbidity

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.

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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Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau

Starting date: November 2003
Ending date: November 2004
Last updated: February 18, 2008