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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:
ClinicalTrials.gov Identifier:
NCT01150786
First Posted: June 25, 2010
Last Update Posted: February 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
maryam ekramzadeh, Shiraz University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Subjective global Assessment(SGA)score [ Time Frame: 12 Weeks ]
    change in nutritional status according to SGA from baseline to the end of intervention


Secondary Outcome Measures:
  • Serum HSCRP [ Time Frame: 12Weeks ]
  • serum ferritin [ Time Frame: 12Weeks ]
  • transferrin [ Time Frame: 12 weeks ]
  • Serum adiponectin [ Time Frame: 12Weeks ]
  • Homocystein [ Time Frame: 12 Weeks ]
  • Serum albumin [ Time Frame: 12Weeks ]
  • Malnutrition inflammation score(MIS) [ Time Frame: 12 Weeks ]
  • Quality of life [ Time Frame: 12 Weeks ]

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: maryam ekramzadeh, Ph.D, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01150786     History of Changes
Other Study ID Numbers: 884746
First Submitted: June 22, 2010
First Posted: June 25, 2010
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

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