Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000238279
Ethics application status
Approved
Date submitted
22/01/2009
Date registered
11/05/2009
Date last updated
2/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Omega-3 oil and bone health
Scientific title
Plant-based omega-3 fatty acid supplementation, acceptability and efficacy for bone health
Secondary ID [1] 287764 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 4223 0
Condition category
Condition code
Musculoskeletal 4442 4442 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 year of oral docosohexanoic acid (DHA) 400 mg daily. DHA is of algal origin (i.e. suitable for vegetarians/vegans). All participants will receive oral vitamin D3 1000 IU daily with calcium carbonate 1200 mg daily
Intervention code [1] 3941 0
Treatment: Drugs
Comparator / control treatment
Oral calcium carbonate 1200 mg with vitamin D3 1000 units daily for 1 year. All participants receive this. Particpants in the placebo group will receive corn oil capsules orally daily for 1 year.
Control group
Active

Outcomes
Primary outcome [1] 5487 0
Bone mineral density (BMD) as measured by Dual Energy X-ray Absorptiometry (DEXA) at entry into study and after 1 year of participation. DEXA is measured by a form of x-ray machine which uses software to compare absorption of 2 different energies of radiation, thus deriving a Bone Mineral Density value in g/cm2
Timepoint [1] 5487 0
1 year from commencement of treatment
Primary outcome [2] 5488 0
change in bone turnover markers as measured by serum N-terminal collagen telopeptide (CTX)
Timepoint [2] 5488 0
1 year from commencement of treatment
Secondary outcome [1] 9242 0
None
Timepoint [1] 9242 0
not applicable

Eligibility
Key inclusion criteria
DEXA BMD T-score between -1.0 and -2.4 (inclusive)

abbreviations as noted above: Bone Mineral density (BMD); Dual Energy X-ray Absorptiometry (DEXA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
already on antiresorptive agents

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)
Recruitment through a DEXA bone mineral density testing service. Potential participants with osteopenic BMD values offered information about participation. Participants randomised to treatment (DHA, Ca, vit D) or control (placebo, Ca, vit D). Allocation is concealed by use of numbered containers. An on-site, third party used a random number generator to allocate numbers to either the active or comparator group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator (computerised sequence generation) used to allocate participants to either
(a) Calcium, vitamin D plus placebo (corn oil capsules); or
(b) Calcium, vitamin D plus DHA
There is no stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2009
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
1/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 4570 0
Charities/Societies/Foundations
Name [1] 4570 0
The Royal Australian College of General Practitioners (RACGP)
Country [1] 4570 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Royal Australian College of General Practitioners (RACGP)
Address
RACGP College House
1 Palmerston Crescent
SOUTH MELBOURNE VIC 3205
Country
Australia
Secondary sponsor category [1] 4123 0
Commercial sector/Industry
Name [1] 4123 0
Martek Biosciences
Address [1] 4123 0
6480 Dobbin Road,
Columbia, MD 21045
Country [1] 4123 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6620 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 6620 0
Ethics committee country [1] 6620 0
Australia
Date submitted for ethics approval [1] 6620 0
Approval date [1] 6620 0
26/03/2008
Ethics approval number [1] 6620 0
H-017-2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29208 0
Dr Simon Vanlint
Address 29208 0
Discipline of General Practice
University of Adelaide SA 5005
Country 29208 0
Australia
Phone 29208 0
+61883134634
Fax 29208 0
Email 29208 0
[email protected]
Contact person for public queries
Name 12455 0
Dr Simon Vanlint
Address 12455 0
Discipline of General Practice
University of Adelaide SA 5005
Country 12455 0
Australia
Phone 12455 0
+61883134634
Fax 12455 0
Email 12455 0
[email protected]
Contact person for scientific queries
Name 3383 0
Dr Simon Vanlint
Address 3383 0
Discipline of General Practice
University of Adelaide SA 5005
Country 3383 0
Australia
Phone 3383 0
+61 8 83034634
Fax 3383 0
Email 3383 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.