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

This study has been completed.
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh Identifier:
First received: September 7, 2006
Last updated: NA
Last verified: May 1993
History: No changes posted
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.

Condition Intervention
Respiratory Tract Infections
Drug: Zinc, or Vitamin A or both

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Immunization test result - IgA(tears, T-lymphocyte number, Proportion, Phenotype, CD4%. CD8%, CD20% PHA, CON-A, PWM at baseline and after 6 weeks.
  • Skin test CM1
  • MUAC
  • Height

Secondary Outcome Measures:
  • Morbidity: new attacks of respiratory infection + duration of respiratory infection
  • Attacks of diarrhoea and duration
  • Fever without respiratory infection

Estimated Enrollment: 147
Study Start Date: July 1993
Estimated Study Completion Date: November 1995
  Show Detailed Description


Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00374023

Dhaka Hospital, ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: Swapan K Roy, MBBS, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information Identifier: NCT00374023     History of Changes
Other Study ID Numbers: 93-012
Study First Received: September 7, 2006
Last Updated: September 7, 2006

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
vitamin A
height gain
weight gain
Children aged between 1 and 3 years
Weight for age between 70% and 61% of NCHS standard
Acute diarrhoeal Patients
No signs of vitamin A deficiency
Who has not received measles vaccine

Additional relevant MeSH terms:
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Respiratory Tract Diseases
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Trace Elements
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents processed this record on May 25, 2017