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OpenTrials
Completed

NCT Number: NCT00296868

Prophylactic Administration of Vitamin C in Wrist Fractures

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.

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Key information

Conditions

RSD (Reflex Sympathetic Dystrophy) Algodystrophy Arm Injuries Autonomic Nervous System Diseases CRPS Type I Complex Regional Pain Syndromes Forearm Injuries Fractures, Bone Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radius Fractures Reflex Sympathetic Dystrophy Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rode Kruis Ziekenhuis, Vondellaan 13

Beverwijk, 1942 LE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ascorbic acid (vitamin C) versus placebo

Drug

Primary outcomes

  1. the existence of CRPS until one year after follow-up

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Stichting Achmea Slachtoffer en Samenleving

Other

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2005
First posted
Feb 27, 2006
Registry last updated
Feb 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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