Status:
UNKNOWN
Effect of Vitamin A Supplementation on Immune Responses in Human Neonates
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
World Health Organization
Conditions:
Vitamin A Deficiency
Eligibility:
All Genders
5-48 years
Phase:
PHASE2
Brief Summary
Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6 months of age, but has a null or detrimental effect when given between 1-5 months. Studies of neonatal VAS ...
Eligibility Criteria
Inclusion
- singleton birth,
- birth weight ≥1,500g,
- mother over 18 years willing to participate and residency within the study area.
- Birth vaccinations and vitamin A supplement must be administered within 48 hours of birth.
Exclusion
- Infants having a congenital disease,
- a serious infection at birth
- an inability to feed (initially assessed by the lack of the suck reflex),
- mothers who are seriously ill at time of enrolment (defined as bed bound for more than 24 hours),
- mother participating in other studies,
- mothers who are HIV positive.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01476358
Start Date
November 1 2011
Last Update
November 14 2012
Active Locations (1)
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1
Medical Research Council, The Gambia Unit
Fajara, The Gambia