Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000342617
Ethics application status
Approved
Date submitted
26/03/2014
Date registered
31/03/2014
Date last updated
31/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised cross-over trial to compare the effects of calcium citrate, dairy products and calcium-fortified fruit juice on serum calcium concentrations in normal postmenopausal women
Scientific title
In postmenopausal women what are the effects of calcium citrate, dairy products and calcium-fortified fruit juice on serum calcium concentrations?
Secondary ID [1] 284335 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 291493 0
Condition category
Condition code
Diet and Nutrition 291858 291858 0 0
Other diet and nutrition disorders
Musculoskeletal 291880 291880 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of each of the following three treatments after fasting for at least 8 hours: 0.5 g of calcium as citrate (oral tablet) after a meal containing protein and fat, 0.5 g of calcium from unfortified dairy products (milk, yoghurt and cheese) or 0.5 g of calcium from a calcium-fortified fruit juice. Each dose will be separated by at least 7 days.
Intervention code [1] 289058 0
Prevention
Comparator / control treatment
A single dose of 0.5 g of calcium as citrate (oral tablet) after fasting for at least 8 hours.
Control group
Active

Outcomes
Primary outcome [1] 291770 0
Change in serum calcium
Timepoint [1] 291770 0
1, 2, 4 and 6 hours after the treatment is ingested
Secondary outcome [1] 307504 0
Change in serum phosphate
Timepoint [1] 307504 0
1, 2, 4 and 6 hours after the treatment is ingested

Eligibility
Key inclusion criteria
Female, postmenopausal 5 years or more (menopause defined as at least 12 months since last period in a woman aged > 45 yrs with intact uterus, or serum oestradiol < 100 pmol/l with FSH > 50 IU/l in younger or hysterectomised woman).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness (including malignancy), active major gastrointestinal disease, metabolic bone diseases, or serum ALP >normal, primary hyperparathyroidism, current or expected use of oral glucocorticoid drugs during the trial period, current or past use of bisphosphonate therapy in the preceding 2 years, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/10/2012
Actual
26/10/2012
Date of last participant enrolment
Anticipated
5/05/2013
Actual
5/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 5927 0
New Zealand
State/province [1] 5927 0
Auckland

Funding & Sponsors
Funding source category [1] 288970 0
Government body
Name [1] 288970 0
Health Research Council
Country [1] 288970 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287651 0
None
Name [1] 287651 0
Address [1] 287651 0
Country [1] 287651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290784 0
Health and Disabilities Ethics Committees
Ethics committee address [1] 290784 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290784 0
New Zealand
Date submitted for ethics approval [1] 290784 0
Approval date [1] 290784 0
01/10/2012
Ethics approval number [1] 290784 0
NTX/10/12/125

Summary
Brief summary
Calcium supplements have been associated with increased cardiovascular risk, which might be related to their acute effects on serum calcium. This study aims to compare the effects on serum calcium of 0.5 g of calcium as citrate fasting, as citrate after a protein and fat rich meal, from unfortified dairy products or from calcium-fortified juice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47250 0
Prof Ian Reid
Address 47250 0
Faculty of Medical and Health Sciences University of Auckland Private Bag 92019 Auckland 1142
Country 47250 0
New Zealand
Phone 47250 0
+64 9 3737 599 ext 86259
Fax 47250 0
Email 47250 0
[email protected]
Contact person for public queries
Name 47251 0
Prof Ian Reid
Address 47251 0
Faculty of Medical and Health Sciences University of Auckland Private Bag 92019 Auckland 1142
Country 47251 0
New Zealand
Phone 47251 0
+64 9 3737 599 ext 86259
Fax 47251 0
Email 47251 0
[email protected]
Contact person for scientific queries
Name 47252 0
Prof Ian Reid
Address 47252 0
Faculty of Medical and Health Sciences University of Auckland Private Bag 92019 Auckland 1142
Country 47252 0
New Zealand
Phone 47252 0
+64 9 3737 599 ext 86259
Fax 47252 0
Email 47252 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
Dimensions AIAcute effects of calcium citrate with or without a meal, calcium-fortified juice and a dairy product meal on serum calcium and phosphate: a randomised cross-over trial2015https://doi.org/10.1017/s000711451500080x
N.B. These documents automatically identified may not have been verified by the study sponsor.