Effect of Selenium Supplementation on Serum Adiponectin and Homocystein
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Subjective global Assessment(SGA)score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Subjective global Assessment(SGA)score
Time Frame: 12 Weeks
change in nutritional status according to SGA from baseline to the end of intervention
Secondary Outcomes
- Serum HSCRP(12Weeks)
- serum ferritin(12Weeks)
- transferrin(12 weeks)
- Serum adiponectin(12Weeks)
- Homocystein(12 Weeks)
- Serum albumin(12Weeks)
- Malnutrition inflammation score(MIS)(12 Weeks)
- Quality of life(12 Weeks)
Investigators
maryam ekramzadeh
Ph.D
Shiraz University of Medical Sciences