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

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Malnutrition; Complication of Hemodialysis
• Intervention / Treatment: Dietary supplement: selenium yeast; Other: placebo capsules

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • shiraz University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.	Dietary supplement: selenium yeast; The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
Placebo Comparator: control group; The patients in this arm took one placebo capsule daily for 12 weeks.	Other: placebo capsules; The patients in this arm took one placebo capsule daily for 12 weeks.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Zahra Sohrabi
• Collaborators: Shiraz University of Medical Sciences
• Investigators: Study Chair: Mohammad mahdi Sagheb, M.D, shiraz University of medical sciences; Principal Investigator: Zahra Sohrabi, Ph.D, shiraz University of medical sciences; Principal Investigator: Moosa Salehi, Ph.D, shiraz University of medical sciences; Principal Investigator: Maryam Ekramzadeh, Ph.D, shiraz University of medical sciences; Principal Investigator: Mohammad Kazem Fallahzadeh, M.D, shiraz University of medical sciences; Principal Investigator: Maryam Ayatollahi, Ph.D, shiraz University of medical sciences; Principal Investigator: Bita Geramizadeh, M.D, shiraz University of medical sciences; Principal Investigator: Jafar Hassanzadeh, Ph.D, shiraz University of medical sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: June 17, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2012
• Last Update Submitted That Met QC Criteria: January 31, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; oxidative stress; Hemodialysis; selenium
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Inflammation; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: 88-4747