Oxidative Stress, Inflammation, Malnutrition
Conditions
Keywords
inflammation, oxidative stress, selenium, hemodialysis
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.
Interventions
DIETARY_SUPPLEMENTSelenium Supplement
The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
OTHERplacebo
The patients in this arm took one placebo capsule daily for 12 weeks.
Sponsors
Shiraz University of Medical Sciences
maryam ekramzadeh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective global Assessment(SGA)score | 12 Weeks | change in nutritional status according to SGA from baseline to the end of intervention |
Secondary
| Measure | Time frame |
|---|---|
| serum ferritin | 12Weeks |
| transferrin | 12 weeks |
| Serum adiponectin | 12Weeks |
| Serum HSCRP | 12Weeks |
| Serum albumin | 12Weeks |
| Malnutrition inflammation score(MIS) | 12 Weeks |
| Quality of life | 12 Weeks |
| Homocystein | 12 Weeks |
Countries
Iran
Outcome results
None listed