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

Phase 3

Completed

• Conditions: Oxidative Stress; Inflammation; Malnutrition
• Interventions: Dietary Supplement: Selenium Supplement; Other: placebo

• Registration Number: NCT01150786
• Lead Sponsor: maryam ekramzadeh

Brief Summary

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

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 Timeline

• Study Start: 2009-04
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
selenium	Selenium Supplement	The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
placebo capsule	placebo	The patients in this arm took one placebo capsule daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Subjective global Assessment(SGA)score	12 Weeks	change in nutritional status according to SGA from baseline to the end of intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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

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