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临床试验/NCT01147354
NCT01147354已完成3 期

Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients

Zahra Sohrabi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年4月最近更新:
适应症

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
1
主要终点
Subjective Global Assessment

研究概览

简要总结

The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

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 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

入选标准

  • Patients who were dialyzed three times a week at least for 3 months or more

排除标准

  • 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

结局指标

主要结局

Subjective Global Assessment

时间窗: 12-weeks

changes in nutritional status according to SGA from baseline to end of treatment

次要结局

  • serum albumin(12-weeks)
  • hemoglobin(12-weeks)
  • serum malondialdehyde(12-weeks)
  • serum parathyroid hormone(12-weeks)
  • serum interleukin-6(12-weeks)
  • serum phosphorus(12-weeks)
  • serum high sensitive c-reactive protein(12-weeks)
  • serum calcium(12-weeks)
  • serum lipoproteins(12-weeks)
  • serum ferritin(12-weeks)
  • serum homocysteine(12-weeks)
  • total iron binding capacity (TIBC)(12-weeks)
  • body mass index (BMI)(12-weeks)
  • malnutrition-inflammation score (MIS)(12-weeks)

研究者

发起方
Zahra Sohrabi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zahra Sohrabi

Ph.D

Shiraz University of Medical Sciences

研究点 (1)

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