RecruitingPhase 3Phase 4ACTRN12610000392066

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

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


Sponsor

Northern Sydney Central Coast Area Health Service, Gosford Hospital

Enrollment

450 participants

Start Date

Sep 1, 2010

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This trial — called REVITAHIP — is studying whether giving high-dose vitamin D supplements soon after a hip fracture can help older adults recover better. Hip fractures are serious injuries for older people and often lead to long-term disability. Vitamin D is important for bone health and muscle strength, and many older adults are deficient. Researchers want to see if quickly correcting low vitamin D levels helps people regain their mobility faster. You may be eligible if: - You are 65 years or older - You have recently broken your hip and had surgery to repair it - You are able to take a loading dose of vitamin D within 7 days after surgery - You (or your authorised representative) can provide informed consent You may NOT be eligible if: - You were unable to walk before your fracture - You are expected to live less than 1 month - You have high calcium levels in your blood - You have a history of kidney stones, thyroid overactivity (thyrotoxicosis), Paget's disease, or active cancer - You have significant kidney or liver problems - You are already taking a high dose of vitamin D (more than 1000 IU per day) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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