Evaluation of the Impact of the WHO Recommended Vitamin A Supplementation at First Immunisation Contact After 6 Months of Age
Information source: Bandim Health Project
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mortality; Morbidity
Intervention: Vitamin A (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bandim Health Project Official(s) and/or principal investigator(s):
Christine S Benn, MD, PhD, Principal Investigator, Affiliation: Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark
Peter Aaby, Dr.Med., Study Director, Affiliation: Bandim Health Project, Apartado 861, 1004 Bissau Codex, Guinea-Bissau
Overall contact:
Ane B Fisker, MD, Phone: +245 201489, Email: a.fisker@bandim.org
Summary
High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%.
The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of
age. However, the effect of providing VAS with vaccines has never been investigated. We have
hypothesised that the effect of VAS depends on the immune stimulus at the time of
supplementation. Hence, the effect might vary depending on which type of vaccine it is given
with. In particular, we hypothesised that VAS might be beneficial when given with measles
vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age
would be a measles vaccine, but many children come late for their DTP vaccinations and
receive DTP alone or together with measles vaccine. Hence, it is important to study whether
the effect of VAS is the same irrespective of the vaccine(s) administered at the same time.
Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with
vaccines, but plans to do so within the next years. Together with the Ministry of Health in
Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect
on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This
will be done in a large randomised trial.
BHP has a demographic surveillance system (DSS) which has followed a population of now more
than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or
placebo with their first vaccine after 6 months of age, and will be followed through the DSS
to assess mortality and morbidity. Based on previous observations, the effects of VAS might
differ according to sex and season. The interaction between VAS, sex, and season will also be
studied in the present trial. By identifying situations where VAS may be beneficial,
ineffective, or even harmful the study may contribute importantly to optimising the VAS
policy for low-income countries.
Clinical Details
Official title: Evaluation of the Impact on Mortality and Morbidity of the WHO Recommended Vitamin A Supplementation at First Immunisation Contact After 6 Months of Age
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Primary outcome: Mortality, morbidity
Secondary outcome: Growth, Vitamin A status, Immunology
Eligibility
Minimum age: 6 Months.
Maximum age: 23 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Urban area: 6-17-month-old children, presenting for vaccination at a health centre in
the study area.
- Rural area: 6-23-month-old children who are missing one or more routine vaccinations
when visited by our mobile team.
Exclusion Criteria:
- Normally applied contraindications for receiving vaccinations, including high fever.
- VAS within last month.
Locations and Contacts
Ane B Fisker, MD, Phone: +245 201489, Email: a.fisker@bandim.org
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau; Recruiting
Peter Aaby, Phone: +245 01489, Email: p.aaby@bandim.org
Peter Aaby, Sub-Investigator
Additional Information
Starting date: August 2007
Last updated: February 18, 2008
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