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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00168597
Other study ID # ICA-CT-2001-10095-VITA
Secondary ID ICA-CT-2001-1009
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated November 14, 2013
Start date August 2002

Study information

Verified date November 2013
Source Bandim Health Project
Contact n/a
Is FDA regulated No
Health authority Guinea-Bissau: Ministry of Health
Study type Interventional

Clinical Trial 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.


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 4,800 normal birth weight infants (> 2500 g) infants randomized to 50,000 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.


Recruitment information / eligibility

Status Completed
Enrollment 4800
Est. completion date
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Inclusion Criteria: Belonging to the study area

Exclusion Criteria:Overt illness, signs of vitamin A deficiency, previous BCG vaccination

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Vitamin A


Locations

Country Name City State
Guinea-Bissau Bandim Health Project, Apartado 861 Bissau

Sponsors (3)

Lead Sponsor Collaborator
Bandim Health Project Leiden University Medical Center, Medical Research Council Unit, The Gambia

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality
Primary Hospitalisations
Secondary Adverse effects
Secondary Tuberculin reaction
Secondary BCG scarring
Secondary Growth
Secondary Vitamin A status
Secondary Cytokine responses
Secondary Malaria
Secondary Measles
Secondary Rotavirus
Secondary All primary and secondary outcomes will be analysed for interactions between vitamin A and sex and last vaccine received
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