Clinical trial NCT01150786: Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients
Official title: Effect of Selenium Supplementation on Serum Adiponectin and Homocystein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oxidative Stress
Inflammation
Malnutrition
Keywords: inflammation
oxidative stress
selenium
hemodialysis
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2010-06-25
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 determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level.

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 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

Primary outcomes:
measure: Subjective global Assessment(SGA)score
timeFrame: 12 Weeks
Secondary outcomes:
measure: Serum HSCRP
timeFrame: 12Weeks
measure: serum ferritin
timeFrame: 12Weeks
measure: transferrin
timeFrame: 12 weeks
measure: Serum adiponectin
timeFrame: 12Weeks
measure: Homocystein
timeFrame: 12 Weeks
measure: Serum albumin
timeFrame: 12Weeks
measure: Malnutrition inflammation score(MIS)
timeFrame: 12 Weeks
measure: Quality of life
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences , nutrition department
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: maryam ekramzade, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: moosa salehi, Ph.D
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences
name: maryam ayatollahi, Ph.D
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Mohammad mahdi Sagheb, M.D
role: STUDY_CHAIR
References: