Vitamin A With BCG Vaccine

This study has been completed.
Sponsor:
Collaborators:
Leiden University Medical Center
Medical Research Council Unit, The Gambia
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168597
First received: September 9, 2005
Last updated: November 14, 2013
Last verified: November 2013

September 9, 2005
November 14, 2013
August 2002
November 2013   (final data collection date for primary outcome measure)
  • Mortality
  • Hospitalisations
Same as current
Complete list of historical versions of study NCT00168597 on ClinicalTrials.gov Archive Site
  • Adverse effects
  • Tuberculin reaction
  • BCG scarring
  • Growth
  • Vitamin A status
  • Cytokine responses
  • Malaria
  • Measles
  • Rotavirus
  • All primary and secondary outcomes will be analysed for interactions between vitamin A and sex and last vaccine received
Same as current
Not Provided
Not Provided
 
Vitamin A With BCG Vaccine
Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Mortality
  • Morbidity
Drug: Vitamin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4800
Not Provided
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria: Belonging to the study area

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

Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT00168597
ICA-CT-2001-10095-VITA, ICA-CT-2001-10095
Not Provided
Not Provided
Bandim Health Project
  • Leiden University Medical Center
  • Medical Research Council Unit, The Gambia
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
Bandim Health Project
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP