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

Inflammation Clinical Trial

Official title:

Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150786
• Other study ID #: 884746
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2010
• Last updated: February 13, 2012
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2012
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran:Shiraz University of Medical Sciences vice counselor for research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Malnutrition
• Oxidative Stress

Intervention

Dietary Supplement:
• Selenium Supplement
The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars
Iran, Islamic Republic of	Shiraz University of Medical Sciences , nutrition department	Shiraz	Fars

Sponsors (2)

Lead Sponsor	Collaborator
maryam ekramzadeh	Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective global Assessment(SGA)score	change in nutritional status according to SGA from baseline to the end of intervention	12 Weeks	No
Secondary	Serum HSCRP		12Weeks	No
Secondary	serum ferritin		12Weeks	No
Secondary	transferrin		12 weeks	No
Secondary	Serum adiponectin		12Weeks	No
Secondary	Homocystein		12 Weeks	No
Secondary	Serum albumin		12Weeks	No
Secondary	Malnutrition inflammation score(MIS)		12 Weeks	No
Secondary	Quality of life		12 Weeks	No