Vitamin A Supplementation With Bacille Calmette Guerin (BCG) Vaccine
Information source: Bandim Health Project
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infant Mortality; Morbidity
Intervention: Vitamin A (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Bandim Health Project Official(s) and/or principal investigator(s): Peter Aaby, Principal Investigator, Affiliation: Bandim Health Project
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: MortalityMorbidity
Secondary outcome: Adverse effectsTuberculin 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.
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.
Eligibility
Minimum age: N/A.
Maximum age: 5 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau
Additional Information
Starting date: November 2004
Last updated: November 14, 2013
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