Adult patients with fractures of the distal radius.
Conditions
Interventions
Product Name: Ascorbic Acid Capsules 500 mg
Product Code: Ascorbic Acid
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Ascorbic Acid
Current Sponsor code: Ascorbic Acid
Other descriptive name
Sponsors
NHS Lothian University, Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Adult patients (>18 years of age) · Unilateral extra-articular or minimal articular un-displaced and displaced distal radial fractures treated with cast, external fixation or open reduction and internal fixation · Patients willing and able to consent · Patients available for review (@ 2, 6, 12 and 26 weeks and 1 year) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patients on vitamin C therapy prior to fractures · Previous distal radial fracture on affected side · Bilateral distal radial fractures · Articular displacement requiring open reduction and internal fixation · Patients who are demented or unable to consent · Patients with history of renal calculi (possible hyperoxaluria) · Patients with a history of glucose 6-phosphate dehydrogenase deficiency and hyperoxaluria · Patients with chronic renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does vitamin C improve hand and wrist function following fractures of the distal radius?;Secondary Objective: - Does vitamin C reduce the incidence of reflex sympathetic dystrophy following fractures of the distal radius? - Does vitamin C increase the rate of fracture healing after fractures of the distal radius? - What is the influence of polymorphic variations in the glutathione perioxidase 1 gene on the clinical outcome after wrist fractues and the on the response to vitamin C treatment?;Primary end point(s): The primary end points or outcome measure si hand and wrist function as assessed by measurement of pain, grip strength, active range of movements and the ability to perform the activities of daily living: - Pain is assessed by a 10 cm visual analogue score and recording of analgesic use - Grip strength is measured by using a JAMAR hand dynamometer - Active range of movements is measured by using a standard full circle goniometer with recordings in triplicate to reduce intra-observer bias. - Ability of perform daily activities is assessed using the standardised "Disabilities of the arm, shoulder and hand (DASH) outcome questionnaires". | — |
Countries
United Kingdom
Outcome results
None listed