Prophylactic Administration of Vitamin C in Wrist Fractures
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ClinicalTrials.gov Identifier: NCT00296868 |
Recruitment Status :
Completed
First Posted : February 27, 2006
Last Update Posted : February 27, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
RSD (Reflex Sympathetic Dystrophy) Algodystrophy CRPS Type I | Drug: ascorbic acid (vitamin C) versus placebo | Phase 4 |
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 (Clinical Trial) |
Enrollment : | 300 participants |
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 : | January 2001 |
Study Completion Date : | December 2005 |

- the existence of CRPS until one year after follow-up
- difference in outcome and dose (dose comparison) after one year of follow-up

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296868
Netherlands | |
Rode Kruis Ziekenhuis, Vondellaan 13 | |
Beverwijk, Netherlands, 1942 LE |
Principal Investigator: | Paul E Zollinger, MD | department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands |
ClinicalTrials.gov Identifier: | NCT00296868 |
Other Study ID Numbers: |
SRvB/2001-290/JV |
First Posted: | February 27, 2006 Key Record Dates |
Last Update Posted: | February 27, 2006 |
Last Verified: | December 2005 |
reflex sympathetic dystrophy ascorbic acid primary prevention radius fractures |
Reflex Sympathetic Dystrophy Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Ascorbic Acid Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |