Prophylactic Administration of Vitamin C in Wrist Fractures

This study has been completed.
Sponsor:
Information provided by:
Stichting Achmea Slachtoffer en Samenleving
ClinicalTrials.gov Identifier:
NCT00296868
First received: February 24, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted

February 24, 2006
February 24, 2006
January 2001
Not Provided
the existence of CRPS until one year after follow-up
Same as current
No Changes Posted
difference in outcome and dose (dose comparison) after one year of follow-up
Same as current
Not Provided
Not Provided
 
Prophylactic Administration of Vitamin C in Wrist Fractures
Prophylactic Administration of Vitamin C in Wrist Fractures; a Randomized Placebo Controlled Multicentre Dose-Finding Study of the Incidence of Complex Regional Pain Syndrome

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • RSD (Reflex Sympathetic Dystrophy)
  • Algodystrophy
  • CRPS Type I
Drug: ascorbic acid (vitamin C) versus placebo
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2005
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00296868
SRvB/2001-290/JV
Not Provided
Not Provided
Stichting Achmea Slachtoffer en Samenleving
Not Provided
Principal Investigator: Paul E Zollinger, MD department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands
Stichting Achmea Slachtoffer en Samenleving
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP