Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
Primary Purpose
Inflammation, Malnutrition, Complication of Hemodialysis
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
selenium yeast
placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Hemodialysis, oxidative stress, selenium, inflammation
Eligibility 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
Sites / Locations
- Shiraz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
The patients in this arm took one placebo capsule daily for 12 weeks.
Outcomes
Primary Outcome Measures
Subjective Global Assessment
changes in nutritional status according to SGA from baseline to end of treatment
Secondary Outcome Measures
serum albumin
hemoglobin
serum malondialdehyde
serum parathyroid hormone
serum interleukin-6
serum phosphorus
serum high sensitive c-reactive protein
serum calcium
serum lipoproteins
serum ferritin
serum homocysteine
total iron binding capacity (TIBC)
body mass index (BMI)
malnutrition-inflammation score (MIS)
Full Information
NCT ID
NCT01147354
First Posted
June 17, 2010
Last Updated
January 31, 2012
Sponsor
Zahra Sohrabi
Collaborators
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01147354
Brief Title
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
Official Title
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zahra Sohrabi
Collaborators
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Malnutrition, Complication of Hemodialysis
Keywords
Hemodialysis, oxidative stress, selenium, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The patients in this arm took one placebo capsule daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium yeast
Intervention Description
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
placebo capsules
Intervention Description
The patients in this arm took one placebo capsule daily for 12 weeks.
Primary Outcome Measure Information:
Title
Subjective Global Assessment
Description
changes in nutritional status according to SGA from baseline to end of treatment
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
serum albumin
Time Frame
12-weeks
Title
hemoglobin
Time Frame
12-weeks
Title
serum malondialdehyde
Time Frame
12-weeks
Title
serum parathyroid hormone
Time Frame
12-weeks
Title
serum interleukin-6
Time Frame
12-weeks
Title
serum phosphorus
Time Frame
12-weeks
Title
serum high sensitive c-reactive protein
Time Frame
12-weeks
Title
serum calcium
Time Frame
12-weeks
Title
serum lipoproteins
Time Frame
12-weeks
Title
serum ferritin
Time Frame
12-weeks
Title
serum homocysteine
Time Frame
12-weeks
Title
total iron binding capacity (TIBC)
Time Frame
12-weeks
Title
body mass index (BMI)
Time Frame
12-weeks
Title
malnutrition-inflammation score (MIS)
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Sohrabi, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad mahdi Sagheb, M.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Moosa Salehi, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maryam Ekramzadeh, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Kazem Fallahzadeh, M.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maryam Ayatollahi, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bita Geramizadeh, M.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jafar Hassanzadeh, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
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