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| Sponsor: | International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00374023 |
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Estimated Enrollment: | 147 |
| Study Start Date: | July 1993 |
| Estimated Study Completion Date: | November 1995 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Bangladesh | |
| Dhaka Hospital, ICDDR,B | |
| Dhaka, Bangladesh, 1212 | |
| 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 |
| Study First Received: | September 7, 2006 |
| Last Updated: | September 7, 2006 |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
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 |
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Diarrhea Respiratory Tract Infections Signs and Symptoms, Digestive Signs and Symptoms Infection Respiratory Tract Diseases Vitamin A Vitamins Zinc Retinol palmitate Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Trace Elements |