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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

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Detailed Description

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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.

Conditions

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Inflammation Malnutrition Complication of Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

selenium yeast

Intervention Type DIETARY_SUPPLEMENT

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

control group

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

Group Type PLACEBO_COMPARATOR

placebo capsules

Intervention Type OTHER

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

Interventions

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selenium yeast

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

Intervention Type DIETARY_SUPPLEMENT

placebo capsules

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zahra Sohrabi

Ph.D

Responsibility Role SPONSOR_INVESTIGATOR