Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000392066
Ethics application status
Approved
Date submitted
11/05/2010
Date registered
14/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 251728 0
None
Universal Trial Number (UTN)
None
Trial acronym
REVITAHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 257337 0
Hypovitaminosis D 257338 0
Rehabilitation 257339 0
Condition category
Condition code
Musculoskeletal 257480 257480 0 0
Osteoporosis
Injuries and Accidents 257481 257481 0 0
Fractures
Physical Medicine / Rehabilitation 257482 257482 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256451 0
Treatment: Drugs
Comparator / control treatment
Participants in the placebo group will receive a one-off dose of 5 x microcelllulose pills initially followed by oral maintenance vitamin D and calcium (800IU vitamin D3, 1000mg calcium).
Control group
Placebo

Outcomes
Primary outcome [1] 258399 0
2.4m gait velocity
Timepoint [1] 258399 0
Baseline, 4 weeks and 26 weeks
Secondary outcome [1] 264137 0
Serum 25-hydroxyvitamin D levels via the DiaSoryn assay
Timepoint [1] 264137 0
Baseline, 2, 4 and 26 weeks
Secondary outcome [2] 264138 0
Falls and fractures (incidence assessed through telephone and face-to-face interviews)
Timepoint [2] 264138 0
Baseline, 2, 4, 12 and 26 weeks
Secondary outcome [3] 264141 0
Quality of life measured by EuroQoL (EQ-5D)
Timepoint [3] 264141 0
Baseline, 2, 4, 12 and 26 weeks
Secondary outcome [4] 264143 0
Adherence to oral maintenance calcium-vitamin D (percentage with 80% adherence), incidence assessed through telephone and face-to-face interviews)
Timepoint [4] 264143 0
Baseline, 2, 4, 12 and 26 weeks
Secondary outcome [5] 264144 0
Grip strength using a portable dynamometer (JAMAR hydraulic Hand Dynamometer manufactured by Sammons Prestons)
Timepoint [5] 264144 0
Baseline, 2, 4 and 26 weeks

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After completion of the baseline assessment, participants will be formally entered into the study and randomised to intervention or control groups. It will be performed centrally by an investigator not involved in recruitment or assessments. The allocation will be concealed by the study staff ringing a central telephone number to be notified to which group the participant has been randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a computer-generated random number schedule with variable block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2890 0
2065
Recruitment postcode(s) [2] 2892 0
2077
Recruitment postcode(s) [3] 2891 0
2103
Recruitment postcode(s) [4] 2889 0
2200
Recruitment postcode(s) [5] 2888 0
2250

Funding & Sponsors
Funding source category [1] 256940 0
Commercial sector/Industry
Name [1] 256940 0
Novartis Australia
Country [1] 256940 0
Australia
Funding source category [2] 264787 0
Charities/Societies/Foundations
Name [2] 264787 0
Royal Australasian College of Physicians (Foundation Scholarship)
Country [2] 264787 0
Australia
Funding source category [3] 264788 0
Hospital
Name [3] 264788 0
Central Coast Area Health Service (Research Grant)
Country [3] 264788 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Central Coast Area Health Service, Gosford Hospital
Address
Department of Geriatric Medicine,
PO Box 361,
Gosford,
New South Wales, 2250
Country
Australia
Secondary sponsor category [1] 256206 0
None
Name [1] 256206 0
Address [1] 256206 0
Country [1] 256206 0
Other collaborator category [1] 1247 0
University
Name [1] 1247 0
Rehabilitation Studies Unit, University of Sydney
Address [1] 1247 0
Northern clinical School - Sydney Medical School
The University of Sydney
PO Box 6
RYDE NSW 1680
Country [1] 1247 0
Australia
Other collaborator category [2] 1250 0
University
Name [2] 1250 0
School of Physiology, Bosch Institute, University of Sydney
Address [2] 1250 0
F13 - Anderson Stuart Building
The University of Sydney
NSW 2006
Country [2] 1250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258945 0
Northern Sydney & Central Coast Health Research Office (HARBOUR)
Ethics committee address [1] 258945 0
The Research Office
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 258945 0
Australia
Date submitted for ethics approval [1] 258945 0
Approval date [1] 258945 0
13/05/2010
Ethics approval number [1] 258945 0
10/HARBR/14

Summary
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
Trial website
None
Trial related presentations / publications
Mak JCS, Stuart-Harris J, Cameron ID, Mason RS. Oral Vitamin D Replacement Following Hip Fracture: A Comparative Review. Journal of the American Geriatrics Society 2010; 58: 382–417.

Mak JCS, Cameron ID, Mason RS. REVITAHIP Protocol. Oral Presentation at the World Congress of Internal Medicine, Melbourne, Australia (20-25th March 2010).
Public notes

Contacts
Principal investigator
Name 31144 0
Address 31144 0
Country 31144 0
Phone 31144 0
Fax 31144 0
Email 31144 0
Contact person for public queries
Name 14391 0
Janine Tritton
Address 14391 0
Department of Geriatric Medicine,
Northern Sydney Central Coast Area Health Service,
Gosford Hospital
PO Box 361
Gosford, NSW, 2250
Country 14391 0
Australia
Phone 14391 0
+612 4320 3141
Fax 14391 0
+612 4320 2986
Email 14391 0
jtritton@nsccahs.health.nsw.gov.au
Contact person for scientific queries
Name 5319 0
Jenson Mak
Address 5319 0
Department of Geriatric Medicine,
Northern Sydney Central Coast Area Health Service,
Gosford Hospital
PO Box 361
Gosford, NSW, 2250
Country 5319 0
Australia
Phone 5319 0
+612 4320 3141
Fax 5319 0
+612 4320 2986
Email 5319 0
jmak@nsccahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23179Study protocol https://bmcgeriatr.biomedcentral.com/articles/10.1186/1471-2318-14-101 
23180Clinical study report https://link.springer.com/article/10.1186/s12891-016-1174-9 

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn initial loading-dose vitamin D versus placebo after hip fracture surgery: randomized trial.2016https://dx.doi.org/10.1186/s12891-016-1174-9
EmbaseAn initial loading-dose vitamin D versus placebo after hip fracture surgery: baseline characteristics of a randomized controlled trial (REVITAHIP).2014https://dx.doi.org/10.1186/1471-2318-14-101
N.B. These documents automatically identified may not have been verified by the study sponsor.