Objective: The aim of this study is to determine the effect of selenium supplementation on metabolic profiles in patients with Congestive Heart Failure (CHF). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with CHF will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHF referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive selenium supplement (n=30) or placebo (n=30). Selenium and placebo tablets are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053033941N2
Registration date:2017-07-04, 1396/04/13
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-07-04, 1396/04/13
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of selenium supplementation on metabolic profiles in patients with congestive heart failure.
Public title
Effect of supplementation in treatment of Congestive Heart Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects aged 45-85 years; diagnosed with CHF. Exclusion Criteria: Unwillingness to cooperate.
Age
From 45 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.Kaums.REC.1396.41
Health conditions studied
1
Description of health condition studied
Congestive Heart Failure
ICD-10 code
I50.0
ICD-10 code description
Congestive Heart Failure
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention