Protocol summary
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Study aim
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The aim of this study is to determine the effects of combined calcium, vitamins D and K supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress among type 2 diabetes patients with coronary heart disease (CVD).
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Design
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In this parallel double-blind randomized controlled clinical trial, patients with type 2 diabetes and CVD will be included in this study. Patients will be assigned to receive either combined calcium, vitamins D and K supplements or placebo. Fasting blood samples will be taken at baseline and after 12-wk intervention to measure biochemical factors.
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Settings and conduct
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This study will be carried out at cardiology clinic affiliated to Kashan University of Medical Sciences (KUMS), Kashan, Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria were as follows: overweight patients (BMI≥25) with T2DM, aged 40-85 years old with CHD condition. Exclusion criteria were consuming vitamin D, K and calcium supplements within the last 3 months, having an acute myocardial infarction within the past 3 months, a cardiac surgery within the past 3 months and a major renal or liver failure.
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Intervention groups
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Patients will be assigned to receive either combined calcium, vitamins D and K supplements (intervention group: n=33) or placebo (control group: n=33).
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Main outcome variables
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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
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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:
IRCT201506185623N45
Registration date:
2015-06-22, 1394/04/01
Registration timing:
registered_while_recruiting
Last update:
2019-09-14, 1398/06/23
Update count:
1
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Registration date
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2015-06-22, 1394/04/01
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-06-02, 1394/03/12
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Expected recruitment end date
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2015-07-09, 1394/04/18
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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 calcium, vitamins D and K co-supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in 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:
Overweight patients (BMI≥25) with T2DM
Aged 40-85 years old with CHD
Exclusion criteria:
Consuming vitamin D, K and calcium supplements within the last 3 months
Having an acute myocardial infarction within the past 3 months
Having a cardiac surgery within the past 3 months
A major renal or liver failure
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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:
66
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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 either vitamin D, K and calcium supplements (n = 33) or placebo (n = 33). 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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the cardiology clinic affiliated to Kashan University of Medical Sciences (KUMS), Kashan, Iran, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2015-06-01, 1394/03/11
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Ethics committee reference number
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IR.Kaums.REC.1394.32
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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Chronic ischaemic heart disease, unspecified
Primary outcomes
1
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Description
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Carotid intima media thickness
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Sonography
Secondary 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
3
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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
4
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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
5
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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
6
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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
7
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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
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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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
10
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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
Intervention groups
1
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Description
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Intervention group: Combined 200 IU vitamin D, 90 µg vitamin K2 and 500 mg calcium supplements daily twice 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, daily, twice 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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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