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

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

Detailed Description
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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.

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

Conditions
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Inflammation, Malnutrition, Complication of Hemodialysis

Intervention / Treatment
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* Dietary Supplement: selenium yeast
* Other: placebo capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks. | Dietary Supplement: selenium yeast<br>* The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.<br>|
| Placebo Comparator: control group<br>The patients in this arm took one placebo capsule daily for 12 weeks. | Other: placebo capsules<br>* The patients in this arm took one placebo capsule daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Global Assessment | changes in nutritional status according to SGA from baseline to end of treatment | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, oxidative stress, selenium, inflammation