Skip to content

Zinc Supplementation on Cellular Immunity in Thalassemia Major

Zinc Supplementation on Cellular Immunity in Thalassemia Major

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03117192
Enrollment
58
Registered
2017-04-17
Start date
2013-09-01
Completion date
2014-02-01
Last updated
2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Splenectomy; Status, Thalassemia

Keywords

zinc supplementation, immunity, thalassemia

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.

Interventions

DRUGZinc Sulfate

Zinc supplementation in syrup form

DRUGSucrose Syrup

Sucrose as placebo, with same taste and consistency as zinc

Sponsors

Fakultas Kedokteran Universitas Indonesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Secretary to the department held an envelope that shows sample allocation after randomization. The envelope is only revealed after data gathering is finished.

Intervention model description

This interventional study is a randomized controlled trial comparing the parallel provision of zinc and placebo in 2 groups of splenectomized thalassemia major patients.

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient's T-lymphocyte count12 weeksMeasurement of patients CD4+ and CD8+ T-lymphocyte count in uL

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026