None listed
Conditions
Brief summary
The REVITAHIP trial is a multicentre randomized-controlled trial examining the effects of early high-dose vitamin D replacement compared to placebo in improving mobility and reducing disability in older people following a hip fracture
Interventions
After surgical fixation and deemed medically stable, participants will be randomly allocated to an intervention group or placebo-control group. For the intervention group, participants will receive an initial oral 250,000IU (5 x 50,000IU) vitamin D3 tablets within 7 days following surgery. Both groups will receive oral maintenance vitamin D3 and calcium (800IU vitamin D3, 1000mg calcium daily) for 26 weeks and will follow the usual hip fracture rehabilitation pathway.
Sponsors
Northern Sydney Central Coast Area Health Service, Gosford Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (aged 65 or over) presenting with a hip fracture requiring surgical treatment 2. Able to provide informed consent, either directly or via the “person responsible” 3. Willingness to participate in and comply with the study 4. Deemed suitable by treating medical team for consent 5. Able to take loading dose by 7 days after operation
Exclusion criteria
1. Unable to read, speak or write English language (and interpreter not available) 2. Bed-bound prior to fracture, or life expectancy deemed less than 1 month (by the treating clinical staff) 3. Hypercalcaemia (serum calcium, >2.65mmol/L). 4. History of renal stones 5. Thyrotoxicosis 6. Paget’s disease 7. Malignancy (except skin cancer) and associated pathological fractures 8. Significant renal impairment (serum creatinine, >0.15mmol/L) 9. Liver disease (alanine aminotransferase or aspartate aminotransferase level >2 times the upper limit of the normal range); 10. Existing treatment with calcitriol or vitamin D2 > than 1000IU daily.
Outcome results
None listed