Prophylactic Administration of Vitamin C in Wrist Fractures - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2006

Last Updated Date

February 24, 2006

Start Date ^†

January 2001

Current Primary Outcome Measures ^†

the existence of CRPS until one year after follow-up

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

RSD (Reflex Sympathetic Dystrophy)
Algodystrophy
CRPS Type I

Intervention ^†

Drug: ascorbic acid (vitamin C) versus placebo

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

300

Completion Date

December 2005

Primary Completion Date

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00296868

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Stichting Achmea Slachtoffer en Samenleving

Collaborators ^††

Investigators ^†

Principal Investigator:

Paul E Zollinger, MD

department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands

Information Provided By

Stichting Achmea Slachtoffer en Samenleving

Verification Date

December 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.