Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effect of selenium supplementation on metabolic profiles in patients with Congestive Heart Failure (CHF).
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Design
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Clinical trial with control group, parallel groups, double blind, randomized, 60 samples, phase 3
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Settings and conduct
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Among CHF patients referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Individuals aged 45-85 years diagnosed with CHF will be included in this study. Exclusion criteria: Exclusion Criteria: Those consuming Selenium supplements within the past 3 months, having an acute myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months and significant renal or hepatic failure.
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Intervention groups
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Intervention group: selenium tablet (Webber Naturals, Mississauga, Canada, 200 µg, daily, for 12 weeks orally. Control group: placebo tablet (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
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Main outcome variables
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Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017053033941N2
Registration date:
2017-07-04, 1396/04/13
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-07-04, 1396/04/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-06-01, 1396/03/11
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Expected recruitment end date
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2017-06-15, 1396/03/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of selenium supplementation on metabolic profiles in patients with congestive heart failure.
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Public title
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Effect of supplementation in treatment of Congestive Heart Failure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion Criteria: Subjects diagnosed with CHF
Individuals aged 45-85 years;
Exclusion criteria:
Those consuming Selenium supplements within the past 3 months,
having an acute myocardial infarction within the past 3 months,
having cardiac surgery within the past 3 months
significant renal or hepatic failure
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Age
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From 45 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of Stat Trek software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-31, 1396/03/10
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Ethics committee reference number
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IR.Kaums.REC.1396.41
Health conditions studied
1
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Description of health condition studied
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Congestive Heart Failure
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ICD-10 code
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I50.0
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ICD-10 code description
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Congestive Heart Failure
Primary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
8
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Systolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
10
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Description
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Diastolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
Intervention groups
1
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Description
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Intervention group: selenium tablet (Webber Naturals, Mississauga, Canada, 200 µg, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo tablet (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available