Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000685112
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
7/05/2019
Date last updated
15/09/2020
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Building bone from blood: The relationship between Vitamin D and Circulating Osteoprogenitor (COP) cells – A pilot study
Scientific title
Building bone from blood: The relationship between Vitamin D and Circulating Osteoprogenitor (COP) cells – A pilot study in otherwise healthy adults with varying levels of Vitamin D, from deficient to sufficient
Secondary ID [1] 298002 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 312441 0
Condition category
Condition code
Musculoskeletal 310991 310991 0 0
Osteoporosis
Diet and Nutrition 311105 311105 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental Group: Bolus dose of 50,000IU vitamin D once, followed by daily 1000IU Vitamin D supplementation for 6 weeks. 6 week supplements will be orally administered by the participant in tablet form.
Bolus dose will be administered orally (tablet) in the presence of the study doctor. Supplements will be provided to the participants to self administer daily. Adherence to supplement regimen will be assessed at subsequent visits verbally.
Intervention code [1] 314228 0
Treatment: Other
Comparator / control treatment
Control Group: 1000IU vitamin D supplement daily for 6 weeks only.
Supplements will be provided to the participants to self administer daily. Adherence to supplement regimen will be assessed at subsequent visits verbally.
Control group
Active

Outcomes
Primary outcome [1] 319788 0
Number of Circulating Osteogenic precursors as assessed on flow cytometry.
Timepoint [1] 319788 0
0 weeks: baseline
3 weeks post enrollment
6 weeks post enrollment
Primary outcome [2] 319789 0
Serum Vitamin D
Timepoint [2] 319789 0
0 weeks: baseline
3 weeks post enrollment
6 weeks post enrollment
Secondary outcome [1] 369536 0
CTX serum assay
Timepoint [1] 369536 0
0 weeks: baseline
3 weeks post enrollment
6 weeks post enrollment
Secondary outcome [2] 369537 0
P1NP serum assay
Timepoint [2] 369537 0
0 weeks: baseline
3 weeks post enrollment
6 weeks post enrollment

Eligibility
Key inclusion criteria
Age > 55yo
Both male and females
Independent in Activities of Daily Living (ADL) (Barthel > 60%)
Vitamin D levels 0-70nmol/L
Normal Bone Mineral Density (BMD) (>-1 SD)
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current smoker
High Body Mass Index (>30)
Diabetes
Hematopoietic / Hematological diseases
Current or prior use of drugs that could interfere with bone mass (ie Glucocorticoids, anti-resorptive drugs, Hormone Replacement Therapy, Teriparatide)
History of recent fracture in the last 3 months
History of bone tumours
Aortic valve calcification by auscultation or previous history
HyperPTH (>6.8pmol/L)

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)
Digital randomization by study statistician, concealment via opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated Block Randomisation stratified by basline vitamin D status
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This pilot study is designed to aid the planning of a larger confirmatory study. The aims of this study are to estimate the size of effect of vitamin D on COP cells required for sample size calculation (and other associated estimates), to determine the timing of primary outcome and to help in determining the appropriate recruitment sample (based on baseline vitamin D levels). A convenient sample of 30 was chosen with equal distribution of vitamin D deficient, insufficient and sufficient participants (10 in each). This was deemed to be feasible to achieve in a given time-frame and provide sufficient information for planning of future confirmatory trial. Results will be reported in accordance with CONSORT guidelines. Detailed descriptive statistics at baseline and at each time point will be presented for a complete group (by intervention group) and for each subgroup (based on baseline vitamin D levels).
Effect of vitamin D bolus injection on %COP at 6 weeks (primary outcome) will be evaluated using ANCOVA adjusting for baseline %COP levels. Outcome will be transformed if required. Model fit will be evaluated by visual examination of residuals and if of poor fit, non-parametric analysis will be performed (rank sum test). Secondary outcomes (changes in COP levels and vitamin D levels over time) and subgroup analysis will be performed using non-parametric tests with focus on detailed descriptive analysis and graphical presentation.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
3/06/2019
Actual
10/07/2019
Date of last participant enrolment
Anticipated
1/10/2020
Actual
20/03/2020
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
30
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13636 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 13637 0
Footscray Hospital - Footscray
Recruitment hospital [3] 13638 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 26307 0
3011 - Footscray
Recruitment postcode(s) [2] 26308 0
3016 - Williamstown
Recruitment postcode(s) [3] 26306 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 302527 0
University
Name [1] 302527 0
The University of Melbourne
Country [1] 302527 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Level 3
The Western Centre for Health Research and Education (WCHRE)
176 Furlong Rd, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 302439 0
None
Name [1] 302439 0
Address [1] 302439 0
Country [1] 302439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303178 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303178 0
Level 2
South West
300 Grattan Street
Parkville Victoria
3052
Ethics committee country [1] 303178 0
Australia
Date submitted for ethics approval [1] 303178 0
01/10/2018
Approval date [1] 303178 0
22/11/2018
Ethics approval number [1] 303178 0
HREC/45058/MH-2018

Summary
Brief summary
This project is investigating the relationship between vitamin D levels, and a recently discovered stem cell called a circulating osteogenic precursor (COP) cell. COP cells are stem cells found in the circulating blood, with the capacity to form bone as well as other tissues such as fat, muscle and cartilage. It is hoped that these cells might be used to treat and manage a range of bone diseases such as fractures and osteoporosis (brittle bones). Vitamin D is known to be important in maintaining bone health, and this trial hopes to uncover whether COP cells play a role in this. This pilot study aims to help us to understand the relationship between vitamin D and COP cells, so that we can plan and run a successful large trial in the future. To achieve this, we want to recruit 30 healthy volunteers with different vitamin D levels, from low to normal. Then we will give half of them a large initial dose of vitamin D, and the other half a placebo pill. Everyone will then get a small vitamin D supplement for 6 weeks. We will measure their COP cell numbers every 3 weeks. We will look for changes in COP cells in those receiving different treatments and also with different starting vitamin D levels. There are no new medications or procedures being trialed in this study, so we expect it to be very safe.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92758 0
Prof Gustavo Duque
Address 92758 0
Level 3,
Western Centre for Health Research and Education
176 Furlong Rd,
St Albans
VIC 3021
Country 92758 0
Australia
Phone 92758 0
+61 3 8395 8121
Fax 92758 0
Email 92758 0
gustavo.duque@unimelb.edu.au
Contact person for public queries
Name 92759 0
Prof Gustavo Duque
Address 92759 0
Level 3,
Western Centre for Health Research and Education
176 Furlong Rd,
St Albans
VIC 3021
Country 92759 0
Australia
Phone 92759 0
+61 3 8395 8121
Fax 92759 0
Email 92759 0
gustavo.duque@unimelb.edu.au
Contact person for scientific queries
Name 92760 0
Prof Gustavo Duque
Address 92760 0
Level 3,
Western Centre for Health Research and Education
176 Furlong Rd,
St Albans
VIC 3021
Country 92760 0
Australia
Phone 92760 0
+61 3 8395 8121
Fax 92760 0
Email 92760 0
gustavo.duque@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to confidential health information, and stipulations of ethics/governance


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.