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Vitamin A Supplementation With Bacille Calmette Guerin (BCG) Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00168610
Recruitment Status : Unknown
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : November 15, 2013
March of Dimes
Leiden University Medical Center
Medical Research Council Unit, The Gambia
Information provided by:
Bandim Health Project

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.


  • 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.

Condition or disease Intervention/treatment Phase
Infant Mortality Morbidity Drug: Vitamin A Phase 4

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 6,000 normal birth weight infants (> 2500 g) randomized to 50,000 or 25,000 IU vitamin A or placebo given simultaneously with BCG vaccine. Study B includes 1,600 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries? Randomized Prospective Studies in Guinea-Bissau
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines Vitamin A

Primary Outcome Measures :
  1. Mortality
  2. Morbidity

Secondary Outcome Measures :
  1. Adverse effects
  2. Tuberculin reaction
  3. BCG scarring
  4. Growth
  5. Vitamin A status
  6. Cytokine responses
  7. Malaria
  8. Measles
  9. Rotavirus
  10. Respiratory syncytial virus (RSV) infection
  11. All primary and secondary outcomes will be analysed for interactions between vitamin A and sex and last vaccine received.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Normal birth weight: belonging to the study area
  • Low birth weight: being born at the national hospital

Exclusion Criteria:

  • Overt illness
  • Signs of vitamin A deficiency
  • Previous BCG vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00168610

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Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
March of Dimes
Leiden University Medical Center
Medical Research Council Unit, The Gambia
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Principal Investigator: Peter Aaby Bandim Health Project
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00168610    
Other Study ID Numbers: 6-FY04-51-VITA2
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by Bandim Health Project:
Vitamin A
Infant mortality
Low-income country
Additional relevant MeSH terms:
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Infant Death
Pathologic Processes
Vitamin A
Physiological Effects of Drugs