Zinc Supplementation on Cellular Immunity in Thalassemia Major

Immunosuppression Clinical Trial

Official title:

Zinc Supplementation on Cellular Immunity in Thalassemia Major

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117192
• Other study ID #: 02
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2017
• Last updated: April 12, 2017
• Start date: September 1, 2013
• Est. completion date: February 1, 2014

Study information

• Verified date: April 2017
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 1, 2014
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• beta-Thalassemia
• Immunosuppression
• Splenectomy; Status
• Thalassemia

Intervention

Drug:
• Zinc Sulfate
Zinc supplementation in syrup form
• Sucrose Syrup
Sucrose as placebo, with same taste and consistency as zinc

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's T-lymphocyte count	Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL	12 weeks