Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome 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 determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level.

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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 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.

Conditions

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Oxidative Stress Inflammation Malnutrition

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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selenium

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

Group Type EXPERIMENTAL

Selenium Supplement

Intervention Type DIETARY_SUPPLEMENT

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

placebo capsule

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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Selenium Supplement

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

Intervention Type DIETARY_SUPPLEMENT

placebo

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No