Replenishment of Vitamin D in Hip fractured Patients (REVITAHIP) Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000392066
• Date of registration: 14/05/2010
• Prospective Registration: Yes
• Primary sponsor: 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: 01/09/2010
• Target sample size: 450
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12610000392066.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Australia

Contacts

• Name: Jenson Mak

• Name: Janine Tritton

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: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Injuries and Accidents - Fractures

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Musculoskeletal - Osteoporosis

Hip Fracture;Hypovitaminosis D;Rehabilitation;
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[Baseline, 4 weeks and 26 weeks]

Secondary Outcome(s)

Grip strength using a portable dynamometer (JAMAR hydraulic Hand Dynamometer manufactured by Sammons Prestons)[Baseline, 2, 4 and 26 weeks]

Serum 25-hydroxyvitamin D levels via the DiaSoryn assay[Baseline, 2, 4 and 26 weeks]

Falls and fractures (incidence assessed through telephone and face-to-face interviews)[Baseline, 2, 4, 12 and 26 weeks]

Quality of life measured by EuroQoL (EQ-5D)[Baseline, 2, 4, 12 and 26 weeks]

Adherence to oral maintenance calcium-vitamin D (percentage with 80% adherence), incidence assessed through telephone and face-to-face interviews)[Baseline, 2, 4, 12 and 26 weeks]

Secondary ID(s)

None

Source(s) of Monetary Support

Novartis Australia

Central Coast Area Health Service (Research Grant)

Royal Australasian College of Physicians (Foundation Scholarship)

Ethics review

Status: Approved
Approval date:
Contact:

Northern Sydney & Central Coast Health Research Office (HARBOUR)