Prophylactic Administration of Vitamin C in Wrist Fractures
Primary Purpose
RSD (Reflex Sympathetic Dystrophy), Algodystrophy, CRPS Type I
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
ascorbic acid (vitamin C) versus placebo
Sponsored by
About this trial
This is an interventional prevention trial for RSD (Reflex Sympathetic Dystrophy) focused on measuring reflex sympathetic dystrophy, ascorbic acid, primary prevention, radius fractures
Eligibility Criteria
Inclusion Criteria: wrist fracture adult (18 years and older) Exclusion Criteria: no comprehension of the written information not able to appear for follow-up (living abroad)
Sites / Locations
- Rode Kruis Ziekenhuis, Vondellaan 13
Outcomes
Primary Outcome Measures
the existence of CRPS until one year after follow-up
Secondary Outcome Measures
difference in outcome and dose (dose comparison) after one year of follow-up
Full Information
NCT ID
NCT00296868
First Posted
February 24, 2006
Last Updated
February 24, 2006
Sponsor
Stichting Achmea Slachtoffer en Samenleving
1. Study Identification
Unique Protocol Identification Number
NCT00296868
Brief Title
Prophylactic Administration of Vitamin C in Wrist Fractures
Official Title
Prophylactic Administration of Vitamin C in Wrist Fractures; a Randomized Placebo Controlled Multicentre Dose-Finding Study of the Incidence of Complex Regional Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stichting Achmea Slachtoffer en Samenleving
4. Oversight
5. Study Description
Brief Summary
Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in literature from 2 - 37%. The female sex is involved three times as much as the male sex. There is one study in literature which describes a prophylactic effect of vitamin C after wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and to replicate these earlier findings.
Detailed Description
The trial was designed as a multicentre, randomized, controlled study. Three hospitals in the Netherlands participated in this study, using the same experimental design.
Adults (18 years or above) with a wrist fracture who were seen in the emergency department of each hospital were asked to participate in this study. Patients were asked to start the trial medication on the day of the fracture. Two capsules had to be taken once daily for 50 days. Patients were allocated randomly to receive either placebo or a dosage of 200, 500 or 1500 mg of vitamin C daily.
The endpoint of the study was defined as the presence of CRPS at any moment, in the period up to one year after the fracture. All participants and physicians were unaware of the treatment allocation.
Patients were seen after 1 week, 4 or 5 weeks (or when the cast was removed), 6 or 7 weeks, 12 weeks, and 26 weeks. After one year patients were interviewed by telephone or received an inquiry letter with a postage-paid envelope for their reply. The normal fracture treatment, either conservative or operative, was not compromised by the protocol, and if necessary patients were seen more often and/or at other times than planned.
Complex regional pain syndrome was diagnosed when four of the following five symptoms were present throughout an area larger than the wrist, including the area distal to the wrist (hand and fingers), and if they occurred or increased after activity: unexplained diffuse pain, which is not in normal relation to the fracture; difference in skin color relative to the other arm; diffuse edema; difference in skin temperature relative to the other arm; limited active range of motion, unrelated to the stage of fracture treatment. If CRPS was diagnosed, the end point of the study was reached and the protocol was terminated to enable treatment for CRPS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSD (Reflex Sympathetic Dystrophy), Algodystrophy, CRPS Type I
Keywords
reflex sympathetic dystrophy, ascorbic acid, primary prevention, radius fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ascorbic acid (vitamin C) versus placebo
Primary Outcome Measure Information:
Title
the existence of CRPS until one year after follow-up
Secondary Outcome Measure Information:
Title
difference in outcome and dose (dose comparison) after one year of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
wrist fracture
adult (18 years and older)
Exclusion Criteria:
no comprehension of the written information
not able to appear for follow-up (living abroad)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Zollinger, MD
Organizational Affiliation
department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rode Kruis Ziekenhuis, Vondellaan 13
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
10636366
Citation
Zollinger PE, Tuinebreijer WE, Kreis RW, Breederveld RS. Effect of vitamin C on frequency of reflex sympathetic dystrophy in wrist fractures: a randomised trial. Lancet. 1999 Dec 11;354(9195):2025-8. doi: 10.1016/S0140-6736(99)03059-7.
Results Reference
result
Learn more about this trial
Prophylactic Administration of Vitamin C in Wrist Fractures
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