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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Treatments: Retinol palmitate; Vitamin A; Vitamins; Zinc

Criteria

Inclusion Criteria:

1. Children aged between 1 and 3 years having weight for age between 70% and 61% of NCHS standard.

2. Who come to the out patient department of ICDDR,B for treatment of acute water diarrhoea with

3. No signs of vitamin A deficiency (non invasive diarrhoea and without systematic infection) and has not received vitamin A during last 4 months.

4. Who has not received measles vaccine and did not have measles primarily identified for the study.

5. Children who has not reside in and around Dhaka city

Exclusion Criteria:

1. Children who needs immediate vitamin A supplementation (clear sign of vitamin deficiency)

2. Children who received vitamin A within the last 4 months

3. Children with other systematic infection

4. Subjects who develop any kind of sign and symptoms of vitamin A deficiency will be given vitamin A and will be analysed separately