Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000261617
Ethics application status
Approved
Date submitted
1/03/2014
Date registered
11/03/2014
Date last updated
11/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C for reducing the severity of pain post distal radius fracture.
Scientific title
Vitamin C for reducing the severity of pain post distal radius fracture.
Secondary ID [1] 284068 0
Nil
Universal Trial Number (UTN)
U1111-1153-2098
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 291127 0
Distal radial fracture 291128 0
Condition category
Condition code
Anaesthesiology 291469 291469 0 0
Pain management
Injuries and Accidents 291470 291470 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288761 0
Prevention
Intervention code [2] 288762 0
Treatment: Drugs
Comparator / control treatment
Approved name: Micro-crystalline cellulose
Trade name: Placebo
Dosage regimen: 1 capsule orally per day for 6 weeks
Known adverse effects: nil known
Known contra-indications/warnings: nil
Control group
Placebo

Outcomes
Primary outcome [1] 291448 0
Post operative pain assessed using the 11 point numerical pain rating scale
Timepoint [1] 291448 0
6 weeks post commencement of treatment
Primary outcome [2] 291630 0
Function as assessed by the DASH and PRWE score
Timepoint [2] 291630 0
6 weeks post commencement of treatment
Secondary outcome [1] 306790 0
Audit of wrist fractures at Mackay Base Hospital which will include mechanism of fracture, type of fracture, type of fixation and number of days between injury and fixation. This secondary outcome will allow us to see if any of these factors influence pain at the 6 week mark
Timepoint [1] 306790 0
6 weeks post commencement of treatment

Eligibility
Key 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.

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed in sealed opaque envelops with the patient’s number. A computer generated random number table will be used to randomise patients
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS will be used to generate relevant descriptive and analytical statistics.

Sample size calculation requires 46 patients for the study.

For pain using VAS or Numerical 11 point pain score
Group sample sizes of 21 and 21 achieve 82% power to detect a difference of 2.0 between the null hypothesis that both group means are 4.0 and the alternative hypothesis that the mean of group 2 is 2.0 with estimated group standard deviations of 2.0 and 2.0 and with a significance level (alpha) of 0.02500 using a two-sided two-sample t-test.

For Function using DASH:
Group sample sizes of 21 and 21 achieve 82% power to detect a difference of 20.0 between the null hypothesis that both group means are 40.0 and the alternative hypothesis that the mean of group 2 is 20.0 with estimated group standard deviations of 20.0 and 20.0 and with a significance level (alpha) of 0.02500 using a two-sided two-sample t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2014
Actual
14/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2143 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 7761 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 288697 0
Hospital
Name [1] 288697 0
Mackay Base Hospital Private Practitioner Fund
Country [1] 288697 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Bridge Road
Mackay, QLD, 4740
Country
Australia
Secondary sponsor category [1] 287402 0
None
Name [1] 287402 0
Address [1] 287402 0
Country [1] 287402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290540 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [1] 290540 0
Ethics committee country [1] 290540 0
Australia
Date submitted for ethics approval [1] 290540 0
Approval date [1] 290540 0
30/08/2013
Ethics approval number [1] 290540 0
13/QTHS/119

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46150 0
Miss Emily Stevenson
Address 46150 0
James Cook University
Mackay Base Hospital
Bridge Road, Mackay, QLD, 4740
Country 46150 0
Australia
Phone 46150 0
+61 490038029
Fax 46150 0
Email 46150 0
[email protected]
Contact person for public queries
Name 46151 0
Ian Verrall
Address 46151 0
Mackay Base Hospital
Bridge Road, Mackay, QLD, 4740
Country 46151 0
Australia
Phone 46151 0
+61
Fax 46151 0
Email 46151 0
[email protected]
Contact person for scientific queries
Name 46152 0
Clare Heal
Address 46152 0
James Cook University
Mackay Base Hospital
Bridge Road, Mackay, QLD, 4740
Country 46152 0
Australia
Phone 46152 0
+61 7 4885 7100
Fax 46152 0
Email 46152 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.