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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338129
First Posted: April 19, 2011
Last Update Posted: April 19, 2011
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.
Information provided by:
Rabin Medical Center
  Purpose
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)

Condition Intervention
Ankle Fracture Dietary Supplement: vitamin c Drug: placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: alon burg, MD 972-54-4854248 alonb@clalit.org.il
Contact: eli sidon, MD 972-52-3896169 elisid@clalit.org.il

Locations
Israel
Beilinson, Rabin Medical Center, Not yet recruiting
Petah Tikva,, Israel
Principal Investigator: alon burg, MD         
Sponsors and Collaborators
Rabin Medical Center
  More Information

Responsible Party: alon burg MD, rabin medical center
ClinicalTrials.gov Identifier: NCT01338129     History of Changes
Other Study ID Numbers: RMC116131CTIL
First Submitted: March 28, 2011
First Posted: April 19, 2011
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:
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
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents