Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00168623
• Other study ID #: 91096-2dos03
• Secondary ID: 91096-03
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 14, 2013
• Start date: November 2003
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6200
• Est. completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morbidity
• Mortality

Intervention

Drug:
• Vitamin A

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project, Apartado 861	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Morbidity
Primary	Both outcomes analysed according to vaccine received and sex