Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168610
Status:
UNKNOWN
Last Update Posted:
2013-11-15
First Post:
2005-09-09
Brief Title:
Vitamin A Supplementation With Bacille Calmette Guerin 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 Randomized Prospective Studies in Guinea-Bissau
Status:
UNKNOWN
Status Verified Date:
2013-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants
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 both normal and low birth weight infants
A lower dose of vitamin A may be even more beneficial than a high dose
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 both normal and low birth weight infants
A lower dose of vitamin A may be even more beneficial than a high dose
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 by 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 the vaccination status of the included infants
In the proposed studies the effect on mortality and morbidity of giving vitamin A supplementation simultaneously with BCG vaccination at birth to both normal and low 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 malaria measles rotavirus infection and RSV infection The mechanisms behind the effects of vitamin A will be evaluated The potential interactions between vitamin A sex and vaccines will be taken into account in all analyses
This will be done in two studies of newborn children Study A includes 6000 normal birth weight infants 2500 g randomized to 50000 or 25000 IU vitamin A or placebo given simultaneously with BCG vaccine Study B includes 1600 low birth weight infants 2500 g randomized to vitamin A or placebo and early BCG or late BCG in a two-by-two factorial design The studies 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 has 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 the vaccination status of the included infants
In the proposed studies the effect on mortality and morbidity of giving vitamin A supplementation simultaneously with BCG vaccination at birth to both normal and low 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 malaria measles rotavirus infection and RSV infection The mechanisms behind the effects of vitamin A will be evaluated The potential interactions between vitamin A sex and vaccines will be taken into account in all analyses
This will be done in two studies of newborn children Study A includes 6000 normal birth weight infants 2500 g randomized to 50000 or 25000 IU vitamin A or placebo given simultaneously with BCG vaccine Study B includes 1600 low birth weight infants 2500 g randomized to vitamin A or placebo and early BCG or late BCG in a two-by-two factorial design The studies 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 has 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 |
|---|---|---|---|
| 6-FY04-51 | None | None | None |