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
  Purpose

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.


Condition Intervention Phase
Mortality
Morbidity
Drug: Vitamin A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality
  • Hospitalisations

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 4800
Study Start Date: August 2002
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Belonging to the study area

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00168597

Locations
Guinea-Bissau
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Leiden University Medical Center
Medical Research Council Unit, The Gambia
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
  More Information

No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168597     History of Changes
Other Study ID Numbers: ICA-CT-2001-10095-VITA, ICA-CT-2001-10095
Study First Received: September 9, 2005
Last Updated: November 14, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Vitamin A
BCG
Infant mortality
Morbidity
Low-income country

Additional relevant MeSH terms:
Vitamins
Vitamin A
Retinol palmitate
BCG Vaccine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on September 29, 2014