Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Conditions
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Oxidative Stress, Inflammation, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Selenium Supplement
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were dialysed three times a week for at least 3 months or more Exclusion Criteria: 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

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: selenium<br>The patients in this arm took 200 microgram selenium yeast daily for 12 weeks. | Dietary Supplement: Selenium Supplement<br>* The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.<br>|
| Placebo Comparator: placebo capsule<br>The patients in this arm took one placebo capsule daily for 12 weeks. | Other: placebo<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(SGA)score | change in nutritional status according to SGA from baseline to the end of intervention | 12 Weeks | 

Secondary Outcome Measures

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

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