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Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

Primary Purpose

Oxidative Stress, Inflammation, Malnutrition

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Selenium Supplement

placebo

About this trial

This is an interventional treatment trial for Oxidative Stress focused on measuring inflammation, oxidative stress, selenium, hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shiraz University of Medical Sciences , nutrition department
Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

selenium

placebo capsule

Arm Description

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

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

Outcomes

Primary Outcome Measures

Subjective global Assessment(SGA)score

change in nutritional status according to SGA from baseline to the end of intervention

Secondary Outcome Measures

Serum HSCRP

serum ferritin

transferrin

Serum adiponectin

Homocystein

Serum albumin

Malnutrition inflammation score(MIS)

Quality of life

Full Information

NCT ID

NCT01150786

First Posted

June 22, 2010

Last Updated

February 13, 2012

Sponsor

maryam ekramzadeh

Collaborators

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01150786

Brief Title

Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

Official Title

Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

maryam ekramzadeh

Collaborators

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oxidative Stress, Inflammation, Malnutrition

Keywords

inflammation, oxidative stress, selenium, hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

selenium

Arm Type

Experimental

Arm Description

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

Arm Title

placebo capsule

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Selenium Supplement

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective global Assessment(SGA)score

Description

change in nutritional status according to SGA from baseline to the end of intervention

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Serum HSCRP

Time Frame

12Weeks

Title

serum ferritin

Time Frame

12Weeks

Title

transferrin

Time Frame

12 weeks

Title

Serum adiponectin

Time Frame

12Weeks

Title

Homocystein

Time Frame

12 Weeks

Title

Serum albumin

Time Frame

12Weeks

Title

Malnutrition inflammation score(MIS)

Time Frame

12 Weeks

Title

Quality of life

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

maryam ekramzade, Ph.D

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

moosa salehi, Ph.D

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

maryam ayatollahi, Ph.D

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohammad mahdi Sagheb, M.D

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Shiraz University of Medical Sciences , nutrition department

City

Shiraz

State/Province

Fars

Country

Iran, Islamic Republic of

Facility Name

Shiraz University of Medical Sciences

City

Shiraz

State/Province

Fars

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

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