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Zinc Supplementation on Cellular Immunity in Thalassemia Major

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ClinicalTrials.gov Identifier: NCT03117192
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Fakultas Kedokteran Universitas Indonesia

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.

Condition or disease Intervention/treatment Phase
Thalassemia Splenectomy; Status Immunosuppression Drug: Zinc Sulfate Drug: Sucrose Syrup Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: Zinc Supplementation on Cellular Immunity in Thalassemia Major
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : February 1, 2014


Arm Intervention/treatment
Experimental: Zinc sulfate
Zinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day.
Drug: Zinc Sulfate
Zinc supplementation in syrup form

Placebo Comparator: Sucrose syrup
Sucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste.
Drug: Sucrose Syrup
Sucrose as placebo, with same taste and consistency as zinc




Primary Outcome Measures :
  1. Patient's T-lymphocyte count [ Time Frame: 12 weeks ]
    Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117192


Locations
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Indonesia
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
Investigators
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Principal Investigator: Teny T Sari, M.D., PhD Faculty of Medicine University of Indonesia

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Responsible Party: Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03117192     History of Changes
Other Study ID Numbers: 02
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fakultas Kedokteran Universitas Indonesia:
zinc supplementation
immunity
thalassemia

Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents