Clinical trial NCT01147354: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Malnutrition
Complication of Hemodialysis
Keywords: Hemodialysis
oxidative stress
selenium
inflammation
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2010-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective Global Assessment
timeFrame: 12-weeks
Secondary outcomes:
measure: serum albumin
timeFrame: 12-weeks
measure: hemoglobin
timeFrame: 12-weeks
measure: serum malondialdehyde
timeFrame: 12-weeks
measure: serum parathyroid hormone
timeFrame: 12-weeks
measure: serum interleukin-6
timeFrame: 12-weeks
measure: serum phosphorus
timeFrame: 12-weeks
measure: serum high sensitive c-reactive protein
timeFrame: 12-weeks
measure: serum calcium
timeFrame: 12-weeks
measure: serum lipoproteins
timeFrame: 12-weeks
measure: serum ferritin
timeFrame: 12-weeks
measure: serum homocysteine
timeFrame: 12-weeks
measure: total iron binding capacity (TIBC)
timeFrame: 12-weeks
measure: body mass index (BMI)
timeFrame: 12-weeks
measure: malnutrition-inflammation score (MIS)
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Zahra Sohrabi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad mahdi Sagheb, M.D
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Moosa Salehi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Maryam Ekramzadeh, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad Kazem Fallahzadeh, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Maryam Ayatollahi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Bita Geramizadeh, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Jafar Hassanzadeh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: