Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000483358
Ethics application status
Approved
Date submitted
5/09/2008
Date registered
29/09/2008
Date last updated
1/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A three month randomised, prospective , single-blind controlled study to determine the effect of two dairy lipid preparations on bone and calcium metabolism in normal post-menopausal women.
Scientific title
Effect of Dairy Lipids on Bone Metabolism in Normal Post-Menopausal Women
Secondary ID [1] 288044 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metabolism 3649 0
Condition category
Condition code
Metabolic and Endocrine 3817 3817 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 grams/day of one of two dairy lipid preparations containing stearic acid/12 weeks. Product A has 15 % stearic acid as a percentage of all fatty acids and
product B has 10 % stearic acid as a percentage of all fatty acids.
Intervention code [1] 3364 0
Treatment: Other
Comparator / control treatment
Normal diet/12 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 4713 0
Serum markers of bone turnover - Serum total alkaline phosphatase, osteocalcin, P1NP and C-telopeptide.
Timepoint [1] 4713 0
baseline, 2,4 8 and 12 weeks
Secondary outcome [1] 7958 0
Urine markers of bone turnover - N-telopeptide and deoxypyridinoline
Timepoint [1] 7958 0
Baseline, 2, 4, 8 and 12 weeks
Secondary outcome [2] 7959 0
Bone mineral density in lumbar spine, proximal femur and total body on Lunar Prodigy Densitometer
Timepoint [2] 7959 0
Baseline and 3 months

Eligibility
Key inclusion criteria
Healthy women at least 5 years post -menopause
Minimum age
45 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Osteoporosis (Bone Mineral Density(BMD) T score <2.5 at hip or spine)
concurrent major systemic illness
renal impairment
chronic liver disease
active major gastrointestinal disease
metabolic bone diease
use of glucocorticoids in preceding 12 mths
use of bisphosphonates or Hormone Replacement Therapy (HRT) or other medications known to cause osteoporosis or interfere with bone metabolism.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible .participants will be allocated to one of three groups, normal diet, or one of two preparations of dairy lipids. Allocation is concealed by the use of numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a variable block size schedule, based on computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
27/11/2008
Date of last participant enrolment
Anticipated
5/03/2009
Actual
5/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 1195 0
New Zealand
State/province [1] 1195 0

Funding & Sponsors
Funding source category [1] 3828 0
Commercial sector/Industry
Name [1] 3828 0
Lactopharma
Country [1] 3828 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Lactopharma
Address
Private Bag 92032, Auckland, 1010.
Country
New Zealand
Secondary sponsor category [1] 3437 0
None
Name [1] 3437 0
Address [1] 3437 0
Country [1] 3437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5881 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5881 0
Private Bag 92 522
Wellesley St
Auckland Central 1010
Ethics committee country [1] 5881 0
New Zealand
Date submitted for ethics approval [1] 5881 0
Approval date [1] 5881 0
26/08/2008
Ethics approval number [1] 5881 0
NTX/08/06/056

Summary
Brief summary
This research study aims to find out whether new preparations of dairy lipids, like butters, have any effectson bone metabolism that might help revent osteoporosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28904 0
Prof Ian Reid
Address 28904 0
University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142
Country 28904 0
New Zealand
Phone 28904 0
+64 9 9236259
Fax 28904 0
Email 28904 0
[email protected]
Contact person for public queries
Name 12061 0
Dr Dr Anne Horne
Address 12061 0
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 12061 0
New Zealand
Phone 12061 0
64 9 9239787
Fax 12061 0
64 9 3072865
Email 12061 0
[email protected]
Contact person for scientific queries
Name 2989 0
Prof Professor Ian Reid
Address 2989 0
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 2989 0
New Zealand
Phone 2989 0
64 9 3737599 ext 86259
Fax 2989 0
Email 2989 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.