Immunosuppression Clinical Trial
Official title:
Zinc Supplementation on Cellular Immunity in Thalassemia Major
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.
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.
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