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NCT01338129 Clinical Trial

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

Ankle Fracture Clinical Trial

— CRPS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01338129
Other study ID # RMC116131CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 28, 2011
Last updated April 18, 2011
Start date April 2011
Est. completion date February 2014

Study information
Verified date March 2011
Source Rabin Medical Center
Contact alon burg, MD
Phone 972-54-4854248
Email alonb@clalit.org.il
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial Summary

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

Description:

There are several studies similar in wrist fracture.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• vitamin c
1000 mg of vitamin c for 45 days
Drug:
• placebo
placebo pills

Locations
Country Name City State
Israel Beilinson, Rabin Medical Center, Petah Tikva,

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months No
See also
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Completed NCT02334618 - Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures N/A
Active, not recruiting NCT02032966 - Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study N/A