Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514891
Status:
TERMINATED
Last Update Posted:
2011-03-01
First Post:
2007-08-08
Brief Title:
Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Evaluation of the Impact on Mortality and Morbidity of the WHO Recommended Vitamin A Supplementation at First Immunisation Contact After 6 Months of Age
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reccomended by DSMB after review of planned interim analyses
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30 The WHO recommends vitamin A supplementation VAS with the first vaccine after 6 months of age However the effect of providing VAS with vaccines has never been investigated We have hypothesised that the effect of VAS depends on the immune stimulus at the time of supplementation Hence the effect might vary depending on which type of vaccine it is given with In particular we hypothesised that VAS might be beneficial when given with measles vaccine but not when given with DTP vaccine Normally the first vaccine after 6 months of age would be a measles vaccine but many children come late for their DTP vaccinations and receive DTP alone or together with measles vaccine Hence it is important to study whether the effect of VAS is the same irrespective of the vaccines administered at the same time
Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines but plans to do so within the next years Together with the Ministry of Health in Guinea-Bissau the Bandim Health Project BHP in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau This will be done in a large randomised trial
BHP has a demographic surveillance system DSS which has followed a population of now more than 150000 individuals for almost 30 years Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age and will be followed through the DSS to assess mortality and morbidity Based on previous observations the effects of VAS might differ according to sex and season The interaction between VAS sex and season will also be studied in the present trial By identifying situations where VAS may be beneficial ineffective or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries
Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines but plans to do so within the next years Together with the Ministry of Health in Guinea-Bissau the Bandim Health Project BHP in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau This will be done in a large randomised trial
BHP has a demographic surveillance system DSS which has followed a population of now more than 150000 individuals for almost 30 years Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age and will be followed through the DSS to assess mortality and morbidity Based on previous observations the effects of VAS might differ according to sex and season The interaction between VAS sex and season will also be studied in the present trial By identifying situations where VAS may be beneficial ineffective or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries
Detailed Description:
None
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