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Trial registered on ANZCTR


Trial ID
ACTRN12614000967684
Ethics application status
Not yet submitted
Date submitted
1/09/2014
Date registered
9/09/2014
Date last updated
9/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathogenesis of long bone fractures in Vitamin D deficient children
Scientific title
The effect of Vitamin D supplementation on fracture healing in Vitamin D deficient children: a placebo controlled trial
Secondary ID [1] 285272 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 292927 0
Fractures 293014 0
Condition category
Condition code
Musculoskeletal 293216 293216 0 0
Other muscular and skeletal disorders
Injuries and Accidents 293263 293263 0 0
Fractures
Diet and Nutrition 293289 293289 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose oral Vitamin D 70,000IU liquid vs placebo. Adherence will be ensured by supervised administration of study drug.
Intervention code [1] 290158 0
Treatment: Drugs
Comparator / control treatment
Placebo liquid administered at the start of the intervention period.
Control group
Placebo

Outcomes
Primary outcome [1] 293081 0
Fracture callous density as assessed by peripheral quantitative computed tomography.
Timepoint [1] 293081 0
Six weeks
Secondary outcome [1] 310301 0
Bone density as assessed by peripheral quantitative computed tomography
Timepoint [1] 310301 0
Six weeks
Secondary outcome [2] 310302 0
Muscle strength evaluated by isometric testing and muscle cross-sectional area as calculated by peripheral quantitative computed tomography.
Timepoint [2] 310302 0
Six weeks

Eligibility
Key inclusion criteria
Age between 8 & 18 at time of recruitment
Voluntary informed consent provided by parent/guardian and children and adolescents aged over 10 years
Presentation within ten days of injury
Conservatively managed fractures including those undergoing a closed manipulation within 24 hours of injury
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age younger than 8 or older than 18 years of age at the commencement of the study
Voluntary informed consent not provided by a parent/guardian and/or children and adolescents aged over 10 years
Fractures managed with an open operation
Fractures manipulated after 24 hours from time of injury
Fracture through a previous fracture site
Fractures consisting of either plastic deformity only

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)
This study will be performed as a double blinded trial. Participants were allocated to treatment groups by the trial pharmacist who held the allocation schedule. The allocation schedule was not available to investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence will be produced using a computer random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome used to analyse fracture healing will be a comparison of fracture callous volumetric tissue density (mg/cm3) and bone strength estimates. This continuous data set is assumed to be approximately normally distributed prior to collection of data, and will be described using mean, standard deviation and range. Summary tables of descriptive statistics will be provided for all baseline variable and efficacy variables. 95% confidence intervals will be presented as appropriate. A sample size calculation was unable to be performed for this study due to the lack of available data. As such the sample size is reflective of a pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2949 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 8654 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 289895 0
University
Name [1] 289895 0
University of Melbourne
Address [1] 289895 0
Northwest Academic Centre
Sunshine Hospital
PO Box 294
St Albans, VIC 3021
Country [1] 289895 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Northwest Academic Centre
Sunshine Hospital
PO Box 294
St Albans, VIC 3021
Country
Australia
Secondary sponsor category [1] 288581 0
None
Name [1] 288581 0
Address [1] 288581 0
Country [1] 288581 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291617 0
Royal Childrens Hospital High Risk Ethics Committee
Ethics committee address [1] 291617 0
50 Flemington Road Parkville Victoria 3052 Australia
Ethics committee country [1] 291617 0
Australia
Date submitted for ethics approval [1] 291617 0
02/09/2014
Approval date [1] 291617 0
Ethics approval number [1] 291617 0

Summary
Brief summary
Peripheral quantitative computed tomography (pQCT) is a novel tool that has the ability to assess trabecular bone independently of cortical bone, and to evaluate various measures of macroscopic bone geometry, which can be combined into indices of bone strength.

A randomised, placebo control trial of vitamin D treatment versus placebo will be performed. Muscle strength and cross sectional muscle area will also be assessed at each follow up time point for all eligible patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51158 0
Dr Michael Bullen
Address 51158 0
University of Melbourne, Sunshine Hospital
Northwest Academic Centre
PO Box 294
St Albans, VIC 3021
Country 51158 0
Australia
Phone 51158 0
+61 3 8395 8078
Fax 51158 0
Email 51158 0
michael.bullen@wh.org.au
Contact person for public queries
Name 51159 0
Dr Michael Bullen
Address 51159 0
University of Melbourne, Sunshine Hospital
Northwest Academic Centre
PO Box 294
St Albans, VIC 3021
Country 51159 0
Australia
Phone 51159 0
+61 3 83958078
Fax 51159 0
Email 51159 0
michael.bullen@wh.org.au
Contact person for scientific queries
Name 51160 0
Dr Michael Bullen
Address 51160 0
University of Melbourne, Sunshine Hospital
Northwest Academic Centre
PO Box 294
St Albans, VIC 3021
Country 51160 0
Australia
Phone 51160 0
+61 3 83958078
Fax 51160 0
Email 51160 0
michael.bullen@wh.org.au