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

April 18, 2011 updated by: Rabin Medical Center

The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are several studies similar in wrist fracture.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah Tikva,, Israel
        • Beilinson, Rabin Medical Center,
        • Principal Investigator:
          • Alon Burg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo pills
Drug: placebo
placebo pills
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 Names:
  • ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC116131CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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