None listed
Conditions
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.
Interventions
Single dose oral Vitamin D 70,000IU liquid vs placebo. Adherence will be ensured by supervised administration of study drug.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
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
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
Outcome results
None listed