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

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01338129

Collaborator

(none)

100

Enrollment

Location

Arms

34.1

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ankle Fracture	Dietary Supplement: vitamin c Drug: placebo	N/A

Detailed Description

There are several studies similar in wrist fracture.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: placebo placebo pills	Drug: placebo placebo pills

Arm

Intervention/Treatment

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

Placebo Comparator: placebo

placebo pills

Drug: placebo

placebo pills

Outcome Measures

Primary Outcome Measures

CRPS incidence [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