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Trial registered on ANZCTR
Registration number
ACTRN12612000232831
Ethics application status
Approved
Date submitted
20/02/2012
Date registered
23/02/2012
Date last updated
8/12/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Relationship between calcium supplements and cardiovascular disease
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Scientific title
Acute effect of calcium supplementation on arterial stiffness and endothelial function in healthy volunteers aged 50 years and over
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Secondary ID [1]
279975
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endothelial function
285892
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Arterial stiffness
285933
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Condition category
Condition code
Cardiovascular
286086
286086
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects will be studied immediately before (i.e on the same day) and 3 hours after 1000 mg calcium citrate orally (one dose)
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Intervention code [1]
284312
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Treatment: Other
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Comparator / control treatment
Baseline results
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Endothelial function assessed by ENDO-PAT 2000
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Assessment method [1]
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Timepoint [1]
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Before and 3 hours after taking calcium supplement
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Secondary outcome [1]
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Arterial stiffness assessed by pulse wave analysis
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Assessment method [1]
296179
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Timepoint [1]
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Before and 3 hours after taking calcium supplement
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Eligibility
Key inclusion criteria
Age > 50 years
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Minimum age
50
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Taking calcium or vitamin D (>300 IU/day) in the last 3 months
Taking proton pump inhibitors in last 3 months
Taking calcium channel blockers in the last 3 months
Primary hyperparathyroidism
Diabetes mellitus
Atrial fibrillation
Raynaud’s phenomenon
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting subjects who meet inclusion and exclusion criteria are enrolled into a single open group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/05/2011
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Actual
17/05/2011
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Date of last participant enrolment
Anticipated
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Actual
23/04/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Foundation Daw Park
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Address [1]
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Repatriation General Hospital
Daws Rd
Daw Park SA 5041
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Country [1]
284745
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Australia
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Primary sponsor type
Individual
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Name
Dr Morton Burt
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Address
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Southern Adelaide Health Service
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Address [1]
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Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
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Country [1]
283637
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
286750
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
286750
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Flinders Drive Flinders Medical Centre Bedford Park SA 5042
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Ethics committee country [1]
286750
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Australia
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Date submitted for ethics approval [1]
286750
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Approval date [1]
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18/04/2011
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Ethics approval number [1]
286750
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1/11/0066
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Summary
Brief summary
Calcium supplements increase bone density and are frequently prescribed to patients with osteoporosis. However, it is not certain whether they reduce the risk of fracture. A recent study from Auckland, New Zealand raised the possibility that calcium supplements might increase the risk of a heart attack (1). Therefore the medical community is reassessing the pros and cons of taking calcium supplements. After taking calcium tablets, the concentration of calcium in blood increases slightly for a few hours. The flow of calcium from blood into the muscle cells that line blood vessels causes them to contract. We hypothesize that the increase in blood calcium after taking calcium tablets makes the blood vessels contract and become stiffer, putting pressure on the heart. This study will assess the stiffness of blood vessels in 20 subjects before and after a single dose of calcium. We hope to determine whether arterial stiffening is a mechanism that could explain a relationship between calcium supplements and an increased risk of heart disease. Reference 1. Bolland MJ, Barber PA, Doughty RN et al. BMJ 2008; 336:262-266
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Trial website
Nil
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Trial related presentations / publications
Burt MG, Mangelsdorf BL, Srivastava D, Petersons CJ. Acute effect of calcium citrate on serum calcium and cardiovascular function. J Bone Miner Res 2013;28:412-418
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Morton Burt
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Address
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Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
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Country
33805
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Australia
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Phone
33805
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61882751094
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Fax
33805
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Email
33805
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[email protected]
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Contact person for public queries
Name
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Morton Burt
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Address
17052
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Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
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Country
17052
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Australia
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Phone
17052
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+61 8 82751094
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Fax
17052
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+61 8 82751215
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Email
17052
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[email protected]
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Contact person for scientific queries
Name
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Morton Burt
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Address
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Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
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Country
7980
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Australia
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Phone
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+61 8 82751094
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Fax
7980
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+61 8 82751215
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Email
7980
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[email protected]
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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.
Download to PDF