Zinc Supplementation on Cellular Immunity in Thalassemia Major
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Patient's T-lymphocyte count
研究概览
简要总结
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.
详细描述
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:
- Seldom receive blood transfusions, if within a time period of one year the subject received blood transfusions of < 1 time.
- Sometimes receive blood transfusions, if within a time period of one year the subject received blood transfusions of 2 - 3 times.
- Often receive blood transfusions, if within a time period of one year the subject received blood transfusions of > 4 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Secretary to the department held an envelope that shows sample allocation after randomization. The envelope is only revealed after data gathering is finished.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thalassemia major patients
- •Age > 12 years
- •Agreed to participate and signed the informed consent
- •No other comorbidity beside thalassemia
排除标准
- •HIV positive patients
- •Those in steroid medication
研究组 & 干预措施
Zinc sulfate
Zinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day.
干预措施: Zinc Sulfate (Drug)
Sucrose syrup
Sucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste.
干预措施: Sucrose Syrup (Drug)
结局指标
主要结局
Patient's T-lymphocyte count
时间窗: 12 weeks
Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL
次要结局
未报告次要终点