Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000274673
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
26/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of calcium supplementation on lipids and bone density in men.
Scientific title
The effect of calcium supplementation on serum lipids and bone density in normal men.
Secondary ID [1] 284668 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal men 362 0
Condition category
Condition code
Other 424 424 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily 600mg calcium (as the citrate) or 1200mg calcium (as the citrate) over 2 years.
Intervention code [1] 322 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 485 0
The difference between the ratio of HDL/LDL cholesterol over 2 years in three treatment groups.
Timepoint [1] 485 0
2 years
Secondary outcome [1] 1048 0
The difference between changes in LDL cholesterol, HDL cholesterol, total cholesterol, HDL/total cholesterol ratio, triglycerides.
Timepoint [1] 1048 0
Over 2 years in the three treatment groups.
Secondary outcome [2] 1049 0
The difference between changes in spine, hip and total body bone mineral density, blood pressure, soft tissue mass and its distribution.
Timepoint [2] 1049 0
Over 2 years in the three treatment groups.

Eligibility
Key inclusion criteria
Males, Age > 40 years, Life expectancy > 5 years.
Minimum age
40 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Coronary heart disease, Diabetes, 5 yr predicted cardiovascular risk of > 15%, Renal impairment (serum creatinine > 0.2mmol/l), Untreated hypo- or hyperthyroidism Active liver disease Serum 25-hydroxyvitamin D < 25 nmol/l Concurrent major systemic disease, including malignancy, Metabolic bone disease, Current treatment for hyperlipidaemia or osteoporosis, Regular use of testosterone replacement therapy within the previous 1 year, Regular use of anabolic steroid preparations in the previous 1 year, Treatment with bisphosphonates in the previous 1 year, Treatment with glucocorticoid drugs in the previous year, Lumbar spine bone density < mean-2.0 SD for age-appropriate data (ie: Z score < -2).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject numbers allocated by personnel based in a different building and having no contact with study subjects
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers in variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2003
Actual
15/04/2004
Date of last participant enrolment
Anticipated
Actual
26/07/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 157 0
New Zealand
State/province [1] 157 0

Funding & Sponsors
Funding source category [1] 476 0
Government body
Name [1] 476 0
Health Research Council of New Zealand
Country [1] 476 0
New Zealand
Primary sponsor type
Individual
Name
Professor I Reid
Address
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 384 0
University
Name [1] 384 0
University of Auckland Bone Research Group
Address [1] 384 0
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country [1] 384 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1454 0
Auckland University
Ethics committee address [1] 1454 0
Ethics committee country [1] 1454 0
Australia
Date submitted for ethics approval [1] 1454 0
Approval date [1] 1454 0
Ethics approval number [1] 1454 0

Summary
Brief summary
This is a 2 year study designed to determine the effect 1g of calcium supplements daily on lipids and bone density in men.
Trial website
Trial related presentations / publications
Reid IR, Ames R, Mason B, Reid HE, Bacon CJ, Bolland MJ, Gamble GD, Grey A, Horne A. Randomized controlled trial of calcium supplementation in healthy, nonosteoporotic, older men. Arch Intern Med 2008;168:2276-82.

Reid IR, Ames R, Mason B, Bolland MJ, Bacon CJ, Reid HE, Kyle C, Gamble GD, Grey A, Horne A. Effects of calcium supplementation on lipids, blood pressure, and body composition in healthy older men: a randomized controlled trial. Am J Clin Nutr 2010;91:131-9.
Public notes

Contacts
Principal investigator
Name 36054 0
Prof Ian Reid
Address 36054 0
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 36054 0
New Zealand
Phone 36054 0
6493737599
Fax 36054 0
Email 36054 0
[email protected]
Contact person for public queries
Name 9511 0
Ms Ruth Ames
Address 9511 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 9511 0
New Zealand
Phone 9511 0
+64 9 3078970
Fax 9511 0
+64 9 3737677
Email 9511 0
[email protected]
Contact person for scientific queries
Name 439 0
Prof Professor Reid
Address 439 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 439 0
New Zealand
Phone 439 0
+64 9 3737599
Fax 439 0
+64 9 3737677
Email 439 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
EmbaseInterventions for preventing falls in older people living in the community.2012https://dx.doi.org/10.1002/14651858.CD007146.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.