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A Study on Immunological Effect of Vitamin A and Zinc in a Placebo Controlled 4 Cell Trial

NCT00374023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2017-11-28

No results posted yet for this study

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.

Conditions

  • Immunity
  • Diarrhea
  • Respiratory Tract Infections

Interventions

DRUG

Zinc, or Vitamin A or both

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Swapan K Roy, MBBS, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-07-01
Primary Completion
1995-11-30
Completion
1995-11-30

Countries

  • Bangladesh

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00374023 on ClinicalTrials.gov