Prophylactic Administration of Vitamin C in Wrist Fractures

Sponsor

Stichting Achmea Slachtoffer en Samenleving (Other)

Overall Status

Completed

CT.gov ID

NCT00296868

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2001

Study Completion Date :

Dec 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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