Trial Review

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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
Scientific title
Acute effect of calcium supplementation on arterial stiffness and endothelial function in healthy volunteers aged 50 years and over
Secondary ID [1] 279975 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial function 285892 0
Arterial stiffness 285933 0
Condition category
Condition code
Cardiovascular 286086 286086 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 284312 0
Treatment: Other
Comparator / control treatment
Baseline results
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286564 0
Endothelial function assessed by ENDO-PAT 2000
Timepoint [1] 286564 0
Before and 3 hours after taking calcium supplement
Secondary outcome [1] 296179 0
Arterial stiffness assessed by pulse wave analysis
Timepoint [1] 296179 0
Before and 3 hours after taking calcium supplement

Eligibility
Key inclusion criteria
Age > 50 years
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2011
Actual
17/05/2011
Date of last participant enrolment
Anticipated
Actual
23/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284745 0
Charities/Societies/Foundations
Name [1] 284745 0
Foundation Daw Park
Country [1] 284745 0
Australia
Primary sponsor type
Individual
Name
Dr Morton Burt
Address
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 283637 0
Hospital
Name [1] 283637 0
Southern Adelaide Health Service
Address [1] 283637 0
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Country [1] 283637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286750 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286750 0
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 286750 0
Australia
Date submitted for ethics approval [1] 286750 0
Approval date [1] 286750 0
18/04/2011
Ethics approval number [1] 286750 0
1/11/0066

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
Trial website
Nil
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
Public notes

Contacts
Principal investigator
Name 33805 0
A/Prof Morton Burt
Address 33805 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 33805 0
Australia
Phone 33805 0
61882751094
Fax 33805 0
Email 33805 0
[email protected]
Contact person for public queries
Name 17052 0
A/Prof Morton Burt
Address 17052 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 17052 0
Australia
Phone 17052 0
+61 8 82751094
Fax 17052 0
+61 8 82751215
Email 17052 0
[email protected]
Contact person for scientific queries
Name 7980 0
A/Prof Morton Burt
Address 7980 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 7980 0
Australia
Phone 7980 0
+61 8 82751094
Fax 7980 0
+61 8 82751215
Email 7980 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.