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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01338129
First received: March 28, 2011
Last updated: April 18, 2011
Last verified: March 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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
Other Name: placebo

Detailed Description:

There are several studies similar in wrist fracture.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: alon burg MD, rabin medical center
ClinicalTrials.gov Identifier: NCT01338129     History of Changes
Other Study ID Numbers: RMC116131CTIL
Study First Received: March 28, 2011
Last Updated: April 18, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

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
Ankle Fractures
Fractures, Bone
Autonomic Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Wounds and Injuries
Ascorbic Acid
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014