Vitamin A With BCG Vaccine

Mortality Clinical Trial

Official title:

Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?

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. 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

• Morbidity
• Mortality

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