Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
2012年1月31日 更新者:Zahra Sohrabi
The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
研究概览
详细说明
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 gave their informed consent to participate in this trial.
Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or taking antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study or if they had been hospitalized in the previous month, we also excluded the ones who were pregnant or had active infections.
The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients were randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and were followed for 12 weeks.In order to determine the nutritional statuses of all patients, at the baseline, the questions of SGA and MIS questionnaire were read to the patients and completed in person by the main investigator.
The questions of SGA and MIS were also asked by the same person at the end of treatment phase.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 cannula just before the beginning of the hemodialysis procedure.
The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C.
Serum levels of malondialdehyde (MDA), interleukin-6 (IL-6), high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium , phosphate, parathyroid hormone (PTH), albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels were measured in all patients at the baseline and at the end of treatment phase of study.The aim of this study was to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
研究类型
介入性
注册 (实际的)
80
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Fars
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Shiraz、Fars、伊朗伊斯兰共和国
- shiraz University of medical sciences
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients who were dialyzed three times a week at least for 3 months or more
Exclusion Criteria:
- Patients who took any multivitamins or immunosuppressive drugs within 2 months prior to enrollment in the study
- Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid,omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study
- Patients who were Hospitalized in the previous month
- Patients who had active infections
- Being pregnant
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:experimental group
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
安慰剂比较:control group
The patients in this arm took one placebo capsule daily for 12 weeks.
|
The patients in this arm took one placebo capsule daily for 12 weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Subjective Global Assessment
大体时间:12-weeks
|
changes in nutritional status according to SGA from baseline to end of treatment
|
12-weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
serum albumin
大体时间:12-weeks
|
12-weeks
|
hemoglobin
大体时间:12-weeks
|
12-weeks
|
serum malondialdehyde
大体时间:12-weeks
|
12-weeks
|
serum parathyroid hormone
大体时间:12-weeks
|
12-weeks
|
serum interleukin-6
大体时间:12-weeks
|
12-weeks
|
serum phosphorus
大体时间:12-weeks
|
12-weeks
|
serum high sensitive c-reactive protein
大体时间:12-weeks
|
12-weeks
|
serum calcium
大体时间:12-weeks
|
12-weeks
|
serum lipoproteins
大体时间:12-weeks
|
12-weeks
|
serum ferritin
大体时间:12-weeks
|
12-weeks
|
serum homocysteine
大体时间:12-weeks
|
12-weeks
|
total iron binding capacity (TIBC)
大体时间:12-weeks
|
12-weeks
|
body mass index (BMI)
大体时间:12-weeks
|
12-weeks
|
malnutrition-inflammation score (MIS)
大体时间:12-weeks
|
12-weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Mohammad mahdi Sagheb, M.D、shiraz University of medical sciences
- 首席研究员:Zahra Sohrabi, Ph.D、shiraz University of medical sciences
- 首席研究员:Moosa Salehi, Ph.D、shiraz University of medical sciences
- 首席研究员:Maryam Ekramzadeh, Ph.D、shiraz University of medical sciences
- 首席研究员:Mohammad Kazem Fallahzadeh, M.D、shiraz University of medical sciences
- 首席研究员:Maryam Ayatollahi, Ph.D、shiraz University of medical sciences
- 首席研究员:Bita Geramizadeh, M.D、shiraz University of medical sciences
- 首席研究员:Jafar Hassanzadeh, Ph.D、shiraz University of medical sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2009年7月1日
研究完成 (实际的)
2009年9月1日
研究注册日期
首次提交
2010年6月17日
首先提交符合 QC 标准的
2010年6月17日
首次发布 (估计)
2010年6月22日
研究记录更新
最后更新发布 (估计)
2012年2月2日
上次提交的符合 QC 标准的更新
2012年1月31日
最后验证
2012年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.