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Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

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ClinicalTrials.gov Identifier: NCT00168623
Recruitment Status : Unknown
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
Bandim Health Project

Study Description
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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.


Condition or disease Intervention/treatment Phase
Mortality Morbidity Drug: Vitamin A Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 6200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days
Study Start Date : November 2003
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mortality
  2. Morbidity
  3. Both outcomes analysed according to vaccine received and sex

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168623


Locations
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Guinea-Bissau
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
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Principal Investigator: Peter Aaby, DMSc Bandim Health Project
More Information
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ClinicalTrials.gov Identifier: NCT00168623    
Other Study ID Numbers: 91096-2dos03
91096-03
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by Bandim Health Project:
Vitamin A
Vaccines
Mortality
Morbidity
Additional relevant MeSH terms:
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Vitamin A
Vitamins
Micronutrients
 Nutrients
Growth Substances
Physiological Effects of Drugs