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

Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Malnutrition; Oxidative Stress
• Intervention / Treatment: Dietary supplement: Selenium Supplement; Other: placebo

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 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.

• 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
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences , nutrition department

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 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

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: maryam ekramzadeh
• Collaborators: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: maryam ekramzade, Ph.D, shiraz University of medical sciences; Study Director: moosa salehi, Ph.D, shiraz University of medical sciences; Study Chair: maryam ayatollahi, Ph.D, shiraz University of medical sciences; Study Chair: Mohammad mahdi Sagheb, M.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 22, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 14, 2012
• Last Update Submitted That Met QC Criteria: February 13, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; hemodialysis; oxidative stress; 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: 884746