Viewing Study NCT00168584



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00168584
Status: COMPLETED
Last Update Posted: 2005-09-15
First Post: 2005-09-12

Brief Title: Different Doses of Vitamin A and Childhood Morbidity and Mortality
Sponsor: Bandim Health Project
Organization: Bandim Health Project

Study Overview

Official Title: Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 100000 IU for infants between 6 and 11 months of age and 200000 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
91096-02 None None None