Zinc Supplementation on Cellular Immunity in Thalassemia Major

NCT ID: NCT03117192

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2014-02-01

Brief Summary

Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.

Detailed Description

Thalassemia refers to a hereditary anaemic condition that occurs due to a single gene disorder resulting in a defect in globin production. Infection is an important cause of morbidity and mortality among thalassemia patients worldwide. Thalassemia patients are more prone to infection. Mechanism of this susceptibility is related to altered immune response compounded by splenectomy procedures common in patients with thalassemia. Zinc on the other hand plays important role in immune responses. This study aims to identify zinc supplementation to cellular immunity of splenectomized patients.

Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered. Anamnesis, physical examination, and laboratory results such as peripheral blood, ferritin, transferrin saturation, serum zinc, immunologic markers for cellular immunity (lymphocyte count, CD4+ and CD8+ T lymphocyte count and functions) are evaluated at the start and end of the 12-week study.

Improvement in immune response is defined as an increase in the T lymphocyte count and CD4+ T lymphocyte count, decrease in CD8+, and increase in the CD4+/CD8+ ratio.12 The mean reference value for CD4+/CD8+ ratio is 1.4 (SD 0.6).15 CD4+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin with proportions measured using flow cytometry. Meanwhile, CD8+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin measured using flow cytometry.

The frequency of blood transfusion is calculated from the medical records of the subjects during the past 1 year, which is grouped as follows:

1. Seldom receive blood transfusions, if within a time period of one year the subject received blood transfusions of < 1 time.

2. Sometimes receive blood transfusions, if within a time period of one year the subject received blood transfusions of 2 - 3 times.

3. Often receive blood transfusions, if within a time period of one year the subject received blood transfusions of > 4 times.

Analysis was conducted using Statistical Package for Social Sciences (SPSS) version 20.0. Changes in immunologic parameters between the two groups that are numeric will be analysed using paired t-test for variables with a normal distribution, and Mann-Whitney test for numeric variables with non-normal distributions.

Conditions

Thalassemia; Splenectomy; Status; Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Zinc sulfate

Zinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day.

Group Type: EXPERIMENTAL

Zinc Sulfate

Intervention Type: DRUG

Zinc supplementation in syrup form

Sucrose syrup

Sucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste.

Group Type: PLACEBO_COMPARATOR

Sucrose Syrup

Intervention Type: DRUG

Sucrose as placebo, with same taste and consistency as zinc

Interventions

Zinc Sulfate

Zinc supplementation in syrup form

Intervention Type: DRUG

Sucrose Syrup

Sucrose as placebo, with same taste and consistency as zinc

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Thalassemia major patients
• Age > 12 years
• Agreed to participate and signed the informed consent
• No other comorbidity beside thalassemia

Exclusion Criteria

• HIV positive patients
• Those in steroid medication

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teny T Sari, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine University of Indonesia

Locations

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

02

Identifier Type: -

Identifier Source: org_study_id