The Effect of Vitamin c on Preventing Complex Regional Pa... | NCT01338129

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

NCT01338129

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Apr 19, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Ankle Fracture

Interventions

vitamin c
placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Dec 2013Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin c	Experimental	administration of vitamin c for 45 days following ankle fracture operation	Dietary Supplement: vitamin c
placebo	Placebo Comparator	placebo pills	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin c	Dietary Supplement	1000 mg of vitamin c for 45 days	vitamin c

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
alon burg, MD	Contact	972-54-4854248		alonb@clalit.org.il
eli sidon, MD	Contact	972-52-3896169		elisid@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beilinson, Rabin Medical Center,		Petah Tikva	Israel		Israel

Condition Browse Module

MeSH Terms

ID	Term
D064386	Ankle Fractures
D020918	Complex Regional Pain Syndromes
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D016512	Ankle Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided