None listed
Conditions
Brief summary
Distal radius fractures are one of the most common orthopaedic injuries encountered in Australia. Vitamin C has been identified to potentially decrease the incidence of complex regional pain syndrome post distal radius fractures, however the evidence is still inconclusive regarding pain. It is our intention to identify if implementing daily vitamin C post distal radius fixation reduces pain at 6 weeks.
Interventions
Approved name: Ascorbic Acid
Trade name: Vitamin C
Dosage regimen: 1000mg orally per day for 6 weeks
Known adverse effects:Nausea/vomiting, heartburn, abdominal cramping and headache - these tend to be very minor and of low incidence
Known contraindications/warnings: Haemachomatosis – increases iron uptake from gastro-intestinal tract. Can lead to iron overload.
Patients will commence the intervention within 24 hours of surgery or conservative management.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients shall only be included who are undergoing operative intervention with plate, screws, K-wires or external fixation or those undergoing conservative treatment.
Exclusion criteria
We will exclude multi-trauma, patients with diagnosed pain or functional issues with the involved wrist or chronic pain patients. Exclusion of patients who require washouts post initial surgery or require prosthesis removal/readjustment prior to 6 week mark will also be conducted. Because of Vitamin C’s side effect of increasing iron uptake we will also exclude any patients who have a diagnosed or documented history, or family history of iron uptake disorders, eg. Haemachromatosis. Patients under the age of 18 an those with an intellectual or mental impairment will also be excluded.
Outcome results
None listed