Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000584235
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
14/07/2009
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of vitamin D status on risk of cardiovascular disease.
Scientific title
Impact of vitamin D status on risk of cardiovascular disease in healthy adults.
Secondary ID [1] 288087 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We are studying whether vitamin D deficiency increases cardiovascular risk 237240 0
Condition category
Condition code
Cardiovascular 239561 239561 0 0
Coronary heart disease
Diet and Nutrition 239571 239571 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arterial stiffness and autonomic nervous system activity will be correlated with vitamin D status in a cross-sectional study. Subjects with vitamin D deficiency (25-hydroxy vitamin D < 50 nmol/L) will be restudied 4-6 weeks after replenishment of vitamin D stores (100000 IU vitamin D orally in two doses two weeks apart).
Intervention code [1] 236932 0
Treatment: Drugs
Intervention code [2] 236938 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238359 0
Cross-sectional study: Simple linear regression relationship between serum 25-hydroxy vitamin D levels and pulse wave velocity (PWV) and baroreceptor sensitivity (BRS).
Interventional study: Change in PWV and BRS.
Timepoint [1] 238359 0
Cross-sectional study: One timepoint only.
Interventional study: 2-4 weeks after second (and final) dose of vitamin D.
Secondary outcome [1] 244791 0
Cross-sectional study: Simple linear regression relationship between serum 25-hydroxy vitamin D levels and augmentation index (AIx).
Interventional study: Change in AIx.
Timepoint [1] 244791 0
Cross-sectional study: One timepoint only.
Interventional study: 2-4 weeks after second (and final) dose of vitamin D.

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Treatment with 25-hydroxy vitamin D or 1,25-dihydroxy vitamin D
Beta-blocker medication
Diabetes mellitus
Atrial fibrillation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cross-sectional study: Observational

Open interventional study: Subjects with 25 hydroxy vitamin D < 50 nmol/L will be eligible to participate.
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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2009
Actual
3/09/2009
Date of last participant enrolment
Anticipated
Actual
24/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237323 0
Charities/Societies/Foundations
Name [1] 237323 0
Foundation Daw Park
Country [1] 237323 0
Australia
Primary sponsor type
Government body
Name
Department of Health
Address
Citi Centre Building
11 Hindmarsh Square
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 236808 0
None
Name [1] 236808 0
Address [1] 236808 0
Country [1] 236808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239423 0
Repatriation General Hospital
Ethics committee address [1] 239423 0
Daws Rd
Daw Park
South Australia 5041
Ethics committee country [1] 239423 0
Australia
Date submitted for ethics approval [1] 239423 0
Approval date [1] 239423 0
20/04/2009
Ethics approval number [1] 239423 0
42/07

Summary
Brief summary
The study aims to determine whether vitamin D deficiency is associated with increased cardiovascular risk and whether that risk is reversed by vitamin D replacement.
Trial website
Trial related presentations / publications
Manuscript under preparation.
Public notes

Contacts
Principal investigator
Name 29893 0
A/Prof Morton Burt
Address 29893 0
Southern Adelaide Diabetes and Endocrine Services
Country 29893 0
Australia
Phone 29893 0
61882751094
Fax 29893 0
Email 29893 0
[email protected]
Contact person for public queries
Name 13140 0
Ms Brenda Mangelsdorf
Address 13140 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park
South Australia 5041
Country 13140 0
Australia
Phone 13140 0
+61 8 82751094
Fax 13140 0
Email 13140 0
[email protected]
Contact person for scientific queries
Name 4068 0
A/Prof Dr Morton Burt
Address 4068 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park
South Australia 5041
Country 4068 0
Australia
Phone 4068 0
+61 8 82751094
Fax 4068 0
Email 4068 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
No additional documents have been identified.