Protocol summary
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Study aim
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The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Invituals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Consuming vitamin D supplements within the past 3 months, having an acute myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months, important hepatic failure and adequate vitamin D status.
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Intervention groups
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Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention.
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Main outcome variables
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Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
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:
IRCT201510315623N56
Registration date:
2015-12-02, 1394/09/11
Registration timing:
retrospective
Last update:
2019-09-24, 1398/07/02
Update count:
1
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Registration date
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2015-12-02, 1394/09/11
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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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2015-10-29, 1394/08/07
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Expected recruitment end date
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2015-11-06, 1394/08/15
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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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Effects of long-term vitamin D supplementation compared with the placebo on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
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Public title
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Effect of supplementation in treatment of Coronary Heart Disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Subjects aged 40-85 years
Diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Consuming vitamin D supplements within the past 3 months
Having an acute myocardial infarction within the past 3 months
Having cardiac surgery within the past 3 months
Important hepatic failure
Adequate vitamin D status
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Age
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From 40 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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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take vitamin D supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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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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2015-10-28, 1394/08/06
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Ethics committee reference number
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IR.KAUMS.REC.1394.91
Health conditions studied
1
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Description of health condition studied
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Coronary Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Ischaemic heart disease (chronic) NOS
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 24 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 24 weeks of intervention
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and after 24 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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Triglycerides
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Timepoint
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At the beginning of the study and after 24 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-cholesterol
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Timepoint
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At the beginning of the study and after 24 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 cholesterol
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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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 24 weeks of intervention
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Method of measurement
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Elisa kit
6
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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 24 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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Malondialdehyde
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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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 24 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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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Carotid intima media thickness
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Sonography
Intervention groups
1
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Description
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Control group: Placebo capsule, every 2 weeks, for 24 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks, for 24 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