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

This study has been completed.
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Zahra Sohrabi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01147354
First received: June 17, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Inflammation
Malnutrition
Complication of Hemodialysis
 Dietary Supplement: selenium yeast
Other: placebo capsules
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients

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 [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    changes in nutritional status according to SGA from baseline to end of treatment


Secondary Outcome Measures:
  • serum albumin [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • hemoglobin [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum malondialdehyde [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum parathyroid hormone [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum interleukin-6 [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum phosphorus [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum high sensitive c-reactive protein [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum calcium [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum lipoproteins [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum ferritin [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • serum homocysteine [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • total iron binding capacity (TIBC) [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • body mass index (BMI) [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • malnutrition-inflammation score (MIS) [ 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: 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.

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147354

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Zahra Sohrabi
Shiraz University of Medical Sciences
Investigators
Principal Investigator: Zahra Sohrabi, Ph.D Shiraz University of Medical Sciences
Study Chair: Mohammad mahdi Sagheb, M.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
  More Information

No publications provided

Responsible Party: Zahra Sohrabi, Ph.D, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01147354     History of Changes
Other Study ID Numbers: 88-4747
Study First Received: June 17, 2010
Last Updated: January 31, 2012
Health Authority: Iran:Shiraz University of Medical sciences vice chancellor for research

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

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 21, 2013