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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 16 June 2014
Main ID:  ACTRN12610000392066
Date of registration: 14/05/2010
Prospective Registration: Yes
Primary sponsor: Government body Northern Sydney Central Coast Area Health Service, Gosford Hospital
Public title: Replenishment of Vitamin D in Hip fractured Patients (REVITAHIP) Trial
Scientific title: The effects of a high-dose oral vitamin D loading dose compared with placebo with maintenance oral vitamin D and calcium on correction of hypovitaminosis D, lower extremity function (gait velocity), falls and fractures among older people after hip fracture surgery
Date of first enrolment: 1/09/2010
Target sample size: 450
Recruitment status: Recruiting
URL:  http://www.anzctr.org.au/ACTRN12610000392066.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Phase:  Phase 3 / Phase 4
Countries of recruitment
Australia
Contacts
Name:   Jenson Mak
Address:  Department of Geriatric Medicine, Northern Sydney Central Coast Area Health Service, Gosford Hospital PO Box 361 Gosford, NSW, 2250, Australia
Telephone: +612 4320 3141
Email: jmak@nsccahs.health.nsw.gov.au
Affiliation: 
Name:   Janine Tritton
Address:  Department of Geriatric Medicine, Northern Sydney Central Coast Area Health Service, Gosford Hospital PO Box 361 Gosford, NSW, 2250, Australia
Telephone: +612 4320 3141
Email: jtritton@nsccahs.health.nsw.gov.au
Affiliation: 
Key inclusion & exclusion criteria
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.

Age minimum: 65 Years
Age maximum: 0 No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Hip Fracture
Hypovitaminosis D
Rehabilitation
Intervention(s)
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.
Primary Outcome(s)
2.4m gait velocity
Secondary Outcome(s)
Adherence to oral maintenance calcium-vitamin D (percentage with 80% adherence), incidence assessed through telephone and face-to-face interviews)
Falls and fractures (incidence assessed through telephone and face-to-face interviews)
Grip strength using a portable dynamometer (JAMAR hydraulic Hand Dynamometer manufactured by Sammons Prestons)
Quality of life measured by EuroQoL (EQ-5D)
Serum 25-hydroxyvitamin D levels via the DiaSoryn assay
Secondary ID(s)
None
Source(s) of Monetary Support
Central Coast Area Health Service (Research Grant)
Novartis Australia
Royal Australasian College of Physicians (Foundation Scholarship)
Secondary Sponsor(s)
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