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

Primary Purpose

Ankle Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vitamin c
placebo
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ankle Fracture focused on measuring vitamin c, ascorbic acid, ankle fracture, crps, rds, crps prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beilinson, Rabin Medical Center,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin c

placebo

Arm Description

administration of vitamin c for 45 days following ankle fracture operation

placebo pills

Outcomes

Primary Outcome Measures

CRPS incidence
the incidence of CRPS (according to the IASP or Bruehl diagnostic cruteria) in both population following the fracture will be record and compared

Secondary Outcome Measures

Full Information

First Posted
March 28, 2011
Last Updated
April 18, 2011
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01338129
Brief Title
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
Acronym
CRPS
Official Title
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)
Detailed Description
There are several studies similar in wrist fracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture
Keywords
vitamin c, ascorbic acid, ankle fracture, crps, rds, crps prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin c
Arm Type
Experimental
Arm Description
administration of vitamin c for 45 days following ankle fracture operation
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo pills
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin c
Other Intervention Name(s)
ascorbic acid
Intervention Description
1000 mg of vitamin c for 45 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
CRPS incidence
Description
the incidence of CRPS (according to the IASP or Bruehl diagnostic cruteria) in both population following the fracture will be record and compared
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alon burg, MD
Phone
972-54-4854248
Email
alonb@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
eli sidon, MD
Phone
972-52-3896169
Email
elisid@clalit.org.il
Facility Information:
Facility Name
Beilinson, Rabin Medical Center,
City
Petah Tikva,
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alon burg, MD

12. IPD Sharing Statement

Learn more about this trial

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

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