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

Phase 3

Completed

• Conditions: Inflammation; Malnutrition; Complication of Hemodialysis
• Interventions: Dietary Supplement: selenium yeast; Other: placebo capsules

• Registration Number: NCT01147354
• Lead Sponsor: Zahra Sohrabi

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	selenium yeast	The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
control group	placebo capsules	The patients in this arm took one placebo capsule daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Subjective Global Assessment	12-weeks	changes in nutritional status according to SGA from baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of