A Study on Immunological Effect of Vitamin A and Zinc in a Placebo Controlled 4 Cell Trial
Status:
Completed
Trial end date:
1995-11-30
Target enrollment:
Participant gender:
Summary
Vitamin A deficiency in children is associated with increased mortality and morbidity due to
respiratory tract and diarrhoeal infections. Vitamin A supplementation has been shown in some
studies to reduce morbidity due to respiratory diseases. However, other studies to reduce
could not document such benefit from vitamin A supplementation. The role of vitamin A on
immunity in humans is not yet clear due to inconclusive results. To evaluate immune changes
and compare those with of a known immunopotent agent like zinc, a randomised double blind
study will be carried out in 1-3 year aged children without acute illness and wt/age between
61% and 70% of NCHS standard. Baseline anthropometry and vitamin A status will be determined
using MRDR test and immune status will be estimated. Each group consisting of 50 children
will either receive vitamin A 200,000 IU over 7 days or 40 m elemental zinc daily for 7 days
or both or placebo. After 8 weeks immunity test will be repeated. Immunity tests will include
serum 1gA, 1gM, 1gG an lymphocyte simulation and 8 antigen multiple skin test. Undiminished
children will be given measles vaccine and serum titre will be measured before and after
supplementation. Vitamin A status will be estimated by MRDR test. Vitamin A2 will be given
and 1ml blood sample will be collected after 5 hours to see the ratio of vitamin A1 and A2
(<0.06 as cut off) as the modified relative dose response (MRDR test). Doses of vitamin A or
zinc will be repeated at the completion of 2 month. The results will be compared between
groups and within groups at baseline and after 6 weeks. The study will generate information
which will help to examine the immune response of vitamin A therapy in children as an
underlying factor for reduction in mortality or morbidity. The study will be completed within
a year.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh