None listed
Conditions
Brief summary
Approximately 100 hip fracture cases are expected to be recruited over a 12 month period who are vitamin D insufficient, reside in the Perth metropolitan area, consent to inclusion in the trial and don’t fulfill any exclusion citeria. Vitamin D insufficiency will be defined as a 25 OHD < 50 nmol/L and initially measured using our current assay (Diasorin 25OHD radioimmunoassay). In a randomised fashion all vitamin D insufficient patients will be offered standard therapy with Ostelin 1000 I.U./day (ergocalciferol) or Vigantoletten 1000 I.U./day (Cholecalciferol obtained from Merck, Germany) in addition to matching placebo to prevent unblinding of study design. Those patients consenting to trial entry will have serum collected for intact PTH, whole PTH, ionised calcium, vitamin D binding protein and 1,25 dihydroxyvitamin D at baseline and following three months therapy.
Interventions
Ergocalciferol 1000 IU daily oral therapy plus matching placebo (sugar pills) daily and taken at the same time for 3 months
Sponsors
Medical Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Hip fracture Residing in Perth metropolitan area
Exclusion criteria
Ionised hypercalcemia History of thyrotoxicosis/Cushings in last 2 years Anticonvulsant medication use Current or within last 3 months use of estrogen, raloxifene, calcitriol, anabolic steroids, bisphosphonates, sodium fluoride or corticosteroids Renal failre as defined by serum creatinine > 150 umol/L Patients unlikely to comply or live longer than 3 months
Outcome results
None listed