Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168597
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2005-09-09
Brief Title:
Vitamin A With BCG Vaccine
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries
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:
Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth Hypotheses Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30 reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting
Detailed Description:
Vitamin A deficiency is common in low-income countries Vitamin A supplementation to children above 6 months of age reduces all-cause mortality with 23 to 30 Studies on vitamin A supplementation in infants younger than 6 months of age have reported inconsistent effects on mortality Studies providing supplementation between 1 and 5 months of age have found no effect or even a negative effect However the only two studies of supplementation at birth both conducted in Asia showed substantial significant reductions in infant all-cause mortality
The beneficial effect of neonatal vitamin A supplementation may be a result of correcting the congenital vitamin A deficiency resulting from maternal vitamin A deficiency On the other hand it has been speculated that the beneficial effect of vitamin A supplementation given at birth may in part be explained by a synergistic effect of vitamin A supplementation and BCG vaccination given at the time of birth
The protective effect on mortality of vitamin A supplementation given at birth needs to be confirmed in an African population Furthermore none of the two previous studies have reported data on vaccination status of the included infants
In this study the effect on mortality and morbidity of given vitamin A supplementation simultaneously with BCG vaccination at birth to normal birth weight infants will be investigated in an African population Furthermore the effects of vitamin A supplementation will be evaluated with respect to effect on growth the response to BCG vaccination infant vitamin A status and infant cytokine profile Furthermore the effect on specific diseases such as malaria measles and rotavirus infections The mechanisms behind the effects of vitamin A will be evaluated
We will include 4800 normal birth weight infants 2500 g infants randomized to 50000 IU of vitamin A or placebo given simultaneously with BCG vaccine The study take place in Guinea-Bissau West Africa The study area consists of five districts in the capital of Guinea-Bissau The Bandim Health Project has been working in the study area for almost 25 years and a demographic surveillance system has been established and functioned for many years
The beneficial effect of neonatal vitamin A supplementation may be a result of correcting the congenital vitamin A deficiency resulting from maternal vitamin A deficiency On the other hand it has been speculated that the beneficial effect of vitamin A supplementation given at birth may in part be explained by a synergistic effect of vitamin A supplementation and BCG vaccination given at the time of birth
The protective effect on mortality of vitamin A supplementation given at birth needs to be confirmed in an African population Furthermore none of the two previous studies have reported data on vaccination status of the included infants
In this study the effect on mortality and morbidity of given vitamin A supplementation simultaneously with BCG vaccination at birth to normal birth weight infants will be investigated in an African population Furthermore the effects of vitamin A supplementation will be evaluated with respect to effect on growth the response to BCG vaccination infant vitamin A status and infant cytokine profile Furthermore the effect on specific diseases such as malaria measles and rotavirus infections The mechanisms behind the effects of vitamin A will be evaluated
We will include 4800 normal birth weight infants 2500 g infants randomized to 50000 IU of vitamin A or placebo given simultaneously with BCG vaccine The study take place in Guinea-Bissau West Africa The study area consists of five districts in the capital of Guinea-Bissau The Bandim Health Project has been working in the study area for almost 25 years and a demographic surveillance system has been established and functioned for many years
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 |
|---|---|---|---|
| ICA-CT-2001-10095 | None | None | None |