TerminatedPhase 4ACTRN12614000967684

Pathogenesis of long bone fractures in Vitamin D deficient children

The effect of Vitamin D supplementation on fracture healing in Vitamin D deficient children: a placebo controlled trial


Sponsor

University of Melbourne

Enrollment

50 participants

Start Date

Apr 16, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 8 YearssMax Age: 18 Yearss

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

Single dose oral Vitamin D 70,000IU liquid vs placebo. Adherence will be ensured by supervised administration of study drug.

Single dose oral Vitamin D 70,000IU liquid vs placebo. Adherence will be ensured by supervised administration of study drug.


Locations(1)

Sunshine Hospital - St Albans

VIC, Australia

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