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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Stichting Achmea Slachtoffer en Samenleving:

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

Estimated Enrollment: 300
Study Start Date: January 2001
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296868

Locations
Netherlands
Rode Kruis Ziekenhuis, Vondellaan 13
Beverwijk, Netherlands, 1942 LE
Sponsors and Collaborators
Stichting Achmea Slachtoffer en Samenleving
Investigators
Principal Investigator: Paul E Zollinger, MD department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00296868     History of Changes
Other Study ID Numbers: SRvB/2001-290/JV
Study First Received: February 24, 2006
Last Updated: February 24, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Stichting Achmea Slachtoffer en Samenleving:
reflex sympathetic dystrophy
ascorbic acid
primary prevention
radius fractures

Additional relevant MeSH terms:
Fractures, Bone
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Wounds and Injuries
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014