Objective: The aim of this study is to determine the effects of selenium supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Coronary Heart Disease (CVD). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Invituals aged 45-75 years diagnosed with CVD will be included in this study. Individuals with neurological and physical problems such as Kidney disease coupled with heart disease, patients in addition with heart disease facing Chronic pain from Reins, rheumatism Etc and patients who were used from psychiatric drugs simultaneously will be excluded in the study. Population and sample size: 60 subjects with CVD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 200 µg selenium supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks (July 1, 2014-Sebtember 1, 2014). Outcomes: Fasting plasma glucose (FPG), serum insulin, lipid profiles, inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407015623N22
Registration date:2014-07-21, 1393/04/30
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-07-21, 1393/04/30
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of selenium supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in Coronary Heart Disease
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects aged 45-75 years; diagnosed with CVD.
Exclusion Criteria: Patients with neurological and physical problems such as Kidney disease coupled with heart disease; patients in addition with heart disease facing Chronic pain from Reins, rheumatism Etc; patients who were used from psychiatric drugs simultaneously.