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

NCT00374023 | Completed

• 1 other identifier: 93-012
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Morbidity: new attacks of respiratory infection + duration of respiratory infection

• Attacks of diarrhoea and duration

• Fever without respiratory infection

Interventions

Zinc, or Vitamin A or both DRUG

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 1 and 3 years having weight for age between 70% and 61% of NCHS standard.
• Who come to the out patient department of ICDDR,B for treatment of acute water diarrhoea with
• No signs of vitamin A deficiency (non invasive diarrhoea and without systematic infection) and has not received vitamin A during last 4 months.
• Who has not received measles vaccine and did not have measles primarily identified for the study.
• Children who has not reside in and around Dhaka city

You may not qualify if:

• Children who needs immediate vitamin A supplementation (clear sign of vitamin deficiency)
• Children who received vitamin A within the last 4 months
• Children with other systematic infection
• Subjects who develop any kind of sign and symptoms of vitamin A deficiency will be given vitamin A and will be analysed separately

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital, ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

  PMID: 36994923 DERIVED

MeSH Terms

Conditions

Diarrhea; Respiratory Tract Infections; Weight Gain

Interventions

Zinc; Vitamin A

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Swapan K Roy, MBBS, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: July 1, 1993
• Primary Completion: November 30, 1995
• Study Completion: November 30, 1995
• Last Updated: November 28, 2017

Record last verified: 1993-05

Locations

BA (1)