Prophylactic Administration of Vitamin C in Wrist Fractures

February 24, 2006 updated by: Stichting Achmea Slachtoffer en Samenleving

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Beverwijk, Netherlands, 1942 LE
        • Rode Kruis Ziekenhuis, Vondellaan 13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the existence of CRPS until one year after follow-up

Secondary Outcome Measures

Outcome Measure
difference in outcome and dose (dose comparison) after one year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

February 27, 2006

Last Update Submitted That Met QC Criteria

February 24, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRvB/2001-290/JV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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