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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01147354
Enrollment
80
Registered
2010-06-22
Start date
2009-04-30
Completion date
2009-09-30
Last updated
2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Hemodialysis, Inflammation, Malnutrition

Keywords

Hemodialysis, oxidative stress, selenium, inflammation

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.

Interventions

DIETARY_SUPPLEMENTselenium yeast

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

OTHERplacebo capsules

The patients in this arm took one placebo capsule daily for 12 weeks.

Sponsors

Shiraz University of Medical Sciences
CollaboratorOTHER
Zahra Sohrabi
Lead SponsorOTHER

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 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

Design outcomes

Primary

MeasureTime frameDescription
Subjective Global Assessment12-weekschanges in nutritional status according to SGA from baseline to end of treatment

Secondary

MeasureTime frame
hemoglobin12-weeks
serum malondialdehyde12-weeks
serum parathyroid hormone12-weeks
serum interleukin-612-weeks
serum phosphorus12-weeks
serum high sensitive c-reactive protein12-weeks
serum albumin12-weeks
serum lipoproteins12-weeks
serum ferritin12-weeks
serum homocysteine12-weeks
total iron binding capacity (TIBC)12-weeks
body mass index (BMI)12-weeks
malnutrition-inflammation score (MIS)12-weeks
serum calcium12-weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026