Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

NCT ID: NCT00168623

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 6200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Mortality; Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Vitamin A

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandim Health Project

OTHER

Sponsor Role: lead

Principal Investigators

Peter Aaby, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Locations

Bandim Health Project, Apartado 861

Bissau, , Guinea-Bissau

Countries

Guinea-Bissau

Other Identifiers

91096-03

Identifier Type: -

Identifier Source: secondary_id

91096-2dos03

Identifier Type: -

Identifier Source: org_study_id