Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
研究概览
简要总结
The purpose of the study is to evaluate the effect of Zinc supplementation on health status of hemodialysis patients through measurement of the following before and after Zinc administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also, Evaluation of quality of life of hemodialysis patients before and after Zinc administration using Fatigue severity scale questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under regular hemodialysis for at least 6 months.
- •Clinically stable condition as outpatients.
- •Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).
排除标准
- •Patients taking any antioxidant supplements including vitamin E, Omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study.
- •Patients receiving Al hydroxide phosphate binders.
- •Hospitalization in the previous month before the onset of the trial, or having active infection.
- •Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.
研究组 & 干预措施
Zinc group
Zinc Sulphate Hard Gel Capsules 110 mg once daily for three months plus Epoetin alfa 2000-4000 IU solution for injection andIron Hydroxide Saccharate Complex Solution for injection.
干预措施: Zinc Sulphate (Dietary Supplement)
Zinc group
Zinc Sulphate Hard Gel Capsules 110 mg once daily for three months plus Epoetin alfa 2000-4000 IU solution for injection andIron Hydroxide Saccharate Complex Solution for injection.
干预措施: Epoetin alfa 2000-4000 IU solution for injection (Drug)
Zinc group
Zinc Sulphate Hard Gel Capsules 110 mg once daily for three months plus Epoetin alfa 2000-4000 IU solution for injection andIron Hydroxide Saccharate Complex Solution for injection.
干预措施: Iron Hydroxide Saccharate Complex Solution for injection (Drug)
Placebo group
Corn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.
干预措施: Corn Starch filled Hard Gel Capsules (Other)
Placebo group
Corn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.
干预措施: Epoetin alfa 2000-4000 IU solution for injection (Drug)
Placebo group
Corn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.
干预措施: Iron Hydroxide Saccharate Complex Solution for injection (Drug)
结局指标
主要结局
Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
时间窗: three months
at baseline and after 3 monthes.
次要结局
- Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)(three months)
- Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)(three months)
- Effect on Fatigue (Fatigue Sevrity Scale)(three months)
研究者
Rasha Roshdy Ibrahim El-kady
Teaching Assistant
Ain Shams University