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Prophylactic Administration of Vitamin C in Wrist Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296868
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : February 27, 2006
Information provided by:
Stichting Achmea Slachtoffer en Samenleving

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.

Condition or disease Intervention/treatment Phase
RSD (Reflex Sympathetic Dystrophy) Algodystrophy CRPS Type I Drug: ascorbic acid (vitamin C) versus placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : January 2001
Study Completion Date : December 2005

Primary Outcome Measures :
  1. the existence of CRPS until one year after follow-up

Secondary Outcome Measures :
  1. difference in outcome and dose (dose comparison) after one year of follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296868

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Rode Kruis Ziekenhuis, Vondellaan 13
Beverwijk, Netherlands, 1942 LE
Sponsors and Collaborators
Stichting Achmea Slachtoffer en Samenleving
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Principal Investigator: Paul E Zollinger, MD department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands
Publications of Results:
Layout table for additonal information Identifier: NCT00296868    
Other Study ID Numbers: SRvB/2001-290/JV
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: February 27, 2006
Last Verified: December 2005
Keywords provided by Stichting Achmea Slachtoffer en Samenleving:
reflex sympathetic dystrophy
ascorbic acid
primary prevention
radius fractures
Additional relevant MeSH terms:
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Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents