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

maryam ekramzadeh

Status and phase: Completed; Phase 3

Conditions: Inflammation; Malnutrition; Oxidative Stress

Treatments: Dietary Supplement: Selenium Supplement; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01150786

884746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

selenium

Experimental group

Description:

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

Treatment:

Dietary Supplement: Selenium Supplement

placebo capsule

Placebo Comparator group

Description:

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

Treatment:

Other: placebo