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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Rabin Medical Center

Study Description
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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.
Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01338129


Contacts
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Contact: alon burg, MD 972-54-4854248 alonb@clalit.org.il
Contact: eli sidon, MD 972-52-3896169 elisid@clalit.org.il

Locations
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Israel
Beilinson, Rabin Medical Center,
Petah Tikva,, Israel
Principal Investigator: alon burg, MD         
Sponsors and Collaborators
Rabin Medical Center
More Information
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Responsible Party: alon burg MD, rabin medical center
ClinicalTrials.gov 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
rds
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
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents