Clinical Trial: Vitamin A Supplementation With Bacille Calmette Guerin (BCG) Vaccine

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries? Randomized Prospective Studies in Guinea-Bissau

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.

Detailed Summary:

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, s
Sponsor: Bandim Health Project

Current Primary Outcome:

  • Mortality
  • Morbidity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse effects
  • Tuberculin reaction
  • BCG scarring
  • Growth
  • Vitamin A status
  • Cytokine responses
  • Malaria
  • Measles
  • Rotavirus
  • Respiratory syncytial virus (RSV) infection
  • All primary and secondary outcomes will be analysed for interactions between vitamin A and sex and last vaccine received.


Original Secondary Outcome:

  • Adverse effects
  • Tuberculin reaction
  • BCG scarring
  • Growth
  • Vitamin A status
  • Cytokine responses
  • Malaria
  • Measles
  • Rotavirus
  • RSV infection
  • All primary and secondary outcomes will be analysed for interactions between vitamin A and sex and last vaccine received.


Information By: Bandim Health Project

Dates:
Date Received: September 9, 2005
Date Started: November 2004
Date Completion:
Last Updated: November 14, 2013
Last Verified: November 2013