Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

February 18, 2008

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Mortality
Morbidity
Both outcomes analysed according to vaccine received and sex

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00168623 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment

Condition ^ICMJE

Mortality
Morbidity

Intervention ^ICMJE

Drug: Vitamin A

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

6200

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Guinea-Bissau

Administrative Information

NCT ID ^ICMJE

NCT00168623

Responsible Party

Study ID Numbers ^ICMJE

91096-2dos03, 91096-03

Study Sponsor ^ICMJE

Bandim Health Project

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter Aaby, DMSc

Bandim Health Project

Information Provided By

Bandim Health Project

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP