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The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture (CRPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01338129
Recruitment Status : Unknown
Verified March 2011 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Information provided by:
Rabin Medical Center

Brief Summary:
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)

Condition or disease Intervention/treatment Phase
Ankle Fracture Dietary Supplement: vitamin c Drug: placebo Not Applicable

Detailed Description:
There are several studies similar in wrist fracture.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study
Study Start Date : April 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: vitamin c
administration of vitamin c for 45 days following ankle fracture operation
Dietary Supplement: vitamin c
1000 mg of vitamin c for 45 days
Other Name: ascorbic acid

Placebo Comparator: placebo
placebo pills
Drug: placebo
placebo pills

Primary Outcome Measures :
  1. CRPS incidence [ Time Frame: 6 months ]
    the incidence of CRPS (according to the IASP or Bruehl diagnostic cruteria) in both population following the fracture will be record and compared

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ankle fracture within 3 weeks after the fracture

Exclusion Criteria:

  • pregnant or lactating woman
  • open fracture
  • already treated with vitamin c
  • chronic renal failure

Information from the National Library of Medicine

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 identifier (NCT number): NCT01338129

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Contact: alon burg, MD 972-54-4854248
Contact: eli sidon, MD 972-52-3896169

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Beilinson, Rabin Medical Center,
Petah Tikva,, Israel
Principal Investigator: alon burg, MD         
Sponsors and Collaborators
Rabin Medical Center
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Responsible Party: alon burg MD, rabin medical center Identifier: NCT01338129    
Other Study ID Numbers: RMC116131CTIL
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: March 2011
Keywords provided by Rabin Medical Center:
vitamin c
ascorbic acid
ankle fracture
crps prevention
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Fractures, Bone
Ankle Fractures
Wounds and Injuries
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents