Viewing Study NCT00168636



Ignite Creation Date: 2024-05-05 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00168636
Status: COMPLETED
Last Update Posted: 2013-11-15
First Post: 2005-09-12

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

Study Overview

Official Title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Status: COMPLETED
Status Verified Date: 2013-11
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: We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO Unexpectedly the low dose was clearly better for girls but not for boys The girls response might have depended on the last vaccine received before the OPV and VAS campaign We believe that these findings call for confirmation In connection with a new campaign we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls and furthermore address the potential effect modification by the last vaccine received before the supplementation
Detailed Description: In Guinea-Bissau a combined OPV and VAS campaign took place in November 2002 Given the uncertainty about the best dose of VAS we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality Mortality after supplementation was lower though not significantly so for children who had received the half dose However there was a highly significant inversion of the effect for boys and girls while the low dose was clearly better for girls the full dose might have been slightly better for boys The girls responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign

We believe that these findings call for confirmation In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls and furthermore address the potential effect modification by the last vaccine received before the supplementation

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
91096-04 None None None