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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | November 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Rotavirus infection | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Different Doses of Vitamin A and Childhood Morbidity and Mortality | ||||
| Official Title ICMJE | Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality | ||||
| Brief Summary | Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect. |
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| Detailed Description | Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far. With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Vitamin A | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5400 | ||||
| Completion Date | August 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Between 6 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day - Exclusion Criteria:Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. - |
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| Gender | Both | ||||
| Ages | 6 Months to 5 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Guinea-Bissau | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00168584 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 91096-2dos02, 91096-02 | ||||
| Study Sponsor ICMJE | Bandim Health Project | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bandim Health Project | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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