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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374023
First Posted: September 8, 2006
Last Update Posted: September 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
  Purpose
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
Immunity Diarrhea Respiratory Tract Infections Drug: Zinc, or Vitamin A or both

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374023


Locations
Bangladesh
Dhaka Hospital, ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Swapan K Roy, MBBS, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

ClinicalTrials.gov Identifier: NCT00374023     History of Changes
Other Study ID Numbers: 93-012
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: September 8, 2006
Last Verified: May 1993

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Zinc
vitamin A
immunity
morbidity
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:
Diarrhea
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Infection
Respiratory Tract Diseases
Vitamins
Vitamin A
Zinc
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents