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| Sponsored by: |
Bandim Health Project |
|---|---|
| Information provided by: | Bandim Health Project |
| ClinicalTrials.gov Identifier: | NCT00168623 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment |
| Official Title: | Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days |
| Estimated Enrollment: | 6200 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | November 2004 |
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 |
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 More Information
| Study ID Numbers: | 91096-2dos03, 91096-03 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00168623 |
| Health Authority: | Guinea-Bissau: Ministry of Health |
|
Vitamin A Vaccines Mortality Morbidity |
|
Retinol palmitate Vitamin A |
|
Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |
