Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168623
First received: September 12, 2005
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Mortality
Morbidity
Drug: Vitamin A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality
  • Morbidity
  • Both outcomes analysed according to vaccine received and sex

Estimated Enrollment: 6200
Study Start Date: November 2003
Estimated Study Completion Date: December 2014
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.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
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

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168623

Locations
Guinea-Bissau
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00168623     History of Changes
Other Study ID Numbers: 91096-2dos03, 91096-03
Study First Received: September 12, 2005
Last Updated: November 14, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Vitamin A
Vaccines
Mortality
Morbidity

Additional relevant MeSH terms:
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014