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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147354
• Other study ID #: 88-4747
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2010
• Last updated: January 31, 2012
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2012
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran:Shiraz University of Medical sciences vice chancellor for research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Hemodialysis
• Inflammation
• Malnutrition

Intervention

Dietary Supplement:
• selenium yeast
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.

Other:
• placebo capsules
The patients in this arm took one placebo capsule daily for 12 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (2)

Lead Sponsor	Collaborator
Zahra Sohrabi	Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Global Assessment	changes in nutritional status according to SGA from baseline to end of treatment	12-weeks	No
Secondary	serum albumin		12-weeks	No
Secondary	hemoglobin		12-weeks	No
Secondary	serum malondialdehyde		12-weeks	No
Secondary	serum parathyroid hormone		12-weeks	No
Secondary	serum interleukin-6		12-weeks	No
Secondary	serum phosphorus		12-weeks	No
Secondary	serum high sensitive c-reactive protein		12-weeks	No
Secondary	serum calcium		12-weeks	No
Secondary	serum lipoproteins		12-weeks	No
Secondary	serum ferritin		12-weeks	No
Secondary	serum homocysteine		12-weeks	No
Secondary	total iron binding capacity (TIBC)		12-weeks	No
Secondary	body mass index (BMI)		12-weeks	No
Secondary	malnutrition-inflammation score (MIS)		12-weeks	No