Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000529640
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
20/05/2014
Date last updated
20/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of vitamin D on insulin resistance and endothelial dysfunction in diabetic patients with ischemic heart disease
Scientific title
Effects of vitamin D administration vs. placebo on insulin resistance, endothelial dysfunction and inflammatory markers in diabetic patients with ischemic heart disease
Secondary ID [1] 284437 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 291644 0
ischemic heart disease 291647 0
Condition category
Condition code
Metabolic and Endocrine 292027 292027 0 0
Diabetes
Cardiovascular 292028 292028 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adminstration of a single dose parenteral vitamin D 300000 IU or placebo to diabetic patients with ischemic heart disease
Intervention code [1] 289188 0
Treatment: Drugs
Comparator / control treatment
Placebo contains all of the excipient in oil execpt the active substance vitamin D
Control group
Placebo

Outcomes
Primary outcome [1] 291914 0
Lowering Inflammatory marker, hs-CRP, based on measuring serum level
Timepoint [1] 291914 0
2 month
Primary outcome [2] 291915 0
Improving insulin resistance based on HOMA-IR model
Timepoint [2] 291915 0
2 month
Secondary outcome [1] 307805 0
Alleviation of endothelial function based on ICAM-1 and VCAM-1 measured level
Timepoint [1] 307805 0
2 month

Eligibility
Key inclusion criteria
Patients with diagnosis of type 2 Diabetes mellitus on the basis of ADA criteria and ischemic heart disease based on angiography results
Minimum age
25 Years
Maximum age
62 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of hypersensivity to Vitamin D
2. Renal failure
3.Hypercalcemia
4. Pregnant women
5. Lactating women
6.Hepatic failure (Child-Pugh B and C)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6010 0
Iran, Islamic Republic Of
State/province [1] 6010 0
Tehran

Funding & Sponsors
Funding source category [1] 289088 0
University
Name [1] 289088 0
Shahid Beheshti University of medical Sciences
Country [1] 289088 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of medical Sciences
Address
Velenjak, near Talighani hospital, 3rd street, tehran, Tehran, Iran PO box: 14397-65461
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 287751 0
None
Name [1] 287751 0
Address [1] 287751 0
Country [1] 287751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290876 0
Ethics committee, Shahid Beheshti University of Medical Sciences
Ethics committee address [1] 290876 0
Velenjak, near Talighani hospital, 3rd street, Tehran, Tehran, Iran PO box: 14397-65462
Ethics committee country [1] 290876 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 290876 0
Approval date [1] 290876 0
Ethics approval number [1] 290876 0

Summary
Brief summary
Hypovitaminosis D is a common problem and has negative effects on cardiovascular and metabolic disease like diabetes. So we want to try the effects of Vitamin D vs. placebo on inflammatory and cardiovascular markers and insulin resistance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47722 0
Dr Mohammad abbasinazari
Address 47722 0
Velenjak, near Talighani hospital, 3rd street, Tehran, Tehran, Iran,Shahid Beheshti University of medical sciences PO box: 14397-65461
Country 47722 0
Iran, Islamic Republic Of
Phone 47722 0
+98 2188873704
Fax 47722 0
Email 47722 0
[email protected]
Contact person for public queries
Name 47723 0
Dr Elnaz Shaseb
Address 47723 0
Velenjak, near Talighani hospital, 3rd street, Tehran, Tehran, Iran,Shahid Beheshti University of medical sciences PO box: 14397-65461
Country 47723 0
Iran, Islamic Republic Of
Phone 47723 0
+98 2188873704
Fax 47723 0
Email 47723 0
[email protected]
Contact person for scientific queries
Name 47724 0
Dr Elnaz Shaseb
Address 47724 0
Velenjak, near Talighani hospital, 3rd street, Tehran, Tehran, Iran,Shahid Beheshti University of medical sciences PO box: 14397-65461
Country 47724 0
Iran, Islamic Republic Of
Phone 47724 0
+98 2188873704
Fax 47724 0
Email 47724 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a single dose of vitamin D on glycemic status and C-reactive protein levels in type 2 diabetic patients with ischemic heart disease: a randomized clinical trial.2016https://dx.doi.org/10.1007/s00592-016-0843-3
EmbaseEffects of parenteral vitamin D on the biomarkers of the endothelial function in patients with type 2 diabetes and ischemic heart disease: A randomized clinical trial.2018
Dimensions AIPotential Beneficial Effects of Vitamin D in Coronary Artery Disease2019https://doi.org/10.3390/nu12010099
N.B. These documents automatically identified may not have been verified by the study sponsor.