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

This study has been completed.
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
maryam ekramzadeh, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01150786
First received: June 22, 2010
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Oxidative Stress
Inflammation
Malnutrition
 Dietary Supplement: Selenium Supplement
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Subjective global Assessment(SGA)score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    change in nutritional status according to SGA from baseline to the end of intervention


Secondary Outcome Measures:
  • Serum HSCRP [ Time Frame: 12Weeks ] [ Designated as safety issue: No ]
  • serum ferritin [ Time Frame: 12Weeks ] [ Designated as safety issue: No ]
  • transferrin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum adiponectin [ Time Frame: 12Weeks ] [ Designated as safety issue: No ]
  • Homocystein [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Serum albumin [ Time Frame: 12Weeks ] [ Designated as safety issue: No ]
  • Malnutrition inflammation score(MIS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150786

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences , nutrition department
Shiraz, Fars, Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
maryam ekramzadeh
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
  More Information

No publications provided

Responsible Party: maryam ekramzadeh, Ph.D, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01150786     History of Changes
Other Study ID Numbers: 884746
Study First Received: June 22, 2010
Last Updated: February 13, 2012
Health Authority: Iran:Shiraz University of Medical Sciences vice counselor for research

Keywords provided by Shiraz University of Medical Sciences:
inflammation
oxidative stress
selenium
hemodialysis

Additional relevant MeSH terms:
Inflammation
Malnutrition
Pathologic Processes
Nutrition Disorders
Selenium
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013