Effect of Selenium Supplementation on Serum Adiponectin and Homocystein
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Subjective global Assessment(SGA)score
研究概览
简要总结
The aim of this study is to determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level.
详细描述
After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and give their informed consent to participate in this trial.The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients are randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and followed for 12 weeks.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient. The blood was taken from the patient's arm used for hemodialysis cannulae just before the beginning of the HD session. The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C. Serum levels of adiponectin,high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium, phosphate, albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels (g/dL) were measured in all patients at the baseline and at the end of treatment phase of study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were dialysed three times a week for at least 3 months or more
排除标准
- •Patients who took multivitamins or immunosuppressive medications
- •Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations
- •Patients who had active infection
- •Patients who were hospitalized in the previous month.
- •Being Pregnant
研究组 & 干预措施
placebo capsule
The patients in this arm took one placebo capsule daily for 12 weeks.
干预措施: placebo (Other)
selenium
The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
干预措施: Selenium Supplement (Dietary Supplement)
结局指标
主要结局
Subjective global Assessment(SGA)score
时间窗: 12 Weeks
change in nutritional status according to SGA from baseline to the end of intervention
次要结局
- Serum HSCRP(12Weeks)
- serum ferritin(12Weeks)
- transferrin(12 weeks)
- Serum adiponectin(12Weeks)
- Homocystein(12 Weeks)
- Serum albumin(12Weeks)
- Malnutrition inflammation score(MIS)(12 Weeks)
- Quality of life(12 Weeks)
研究者
maryam ekramzadeh
Ph.D
Shiraz University of Medical Sciences