NCT01338129

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 19, 2011

Status Verified

March 1, 2011

Enrollment Period

2.7 years

First QC Date

March 28, 2011

Last Update Submit

April 18, 2011

Conditions

Ankle Fracture

Keywords

vitamin cascorbic acidankle fracturecrpsrdscrps prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

vitamin cDIETARY_SUPPLEMENT

1000 mg of vitamin c for 45 days

Also known as: ascorbic acid
vitamin c
placeboDRUG

placebo pills

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ankle fracture within 3 weeks after the fracture

You may not qualify if:

  • pregnant or lactating woman
  • open fracture
  • already treated with vitamin c
  • chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beilinson, Rabin Medical Center,

Petah Tikva, Israel, Israel

Location

MeSH Terms

Conditions

Ankle FracturesComplex Regional Pain SyndromesAcute Lung Injury

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesLung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

alon burg, MD

CONTACT

972-54-4854248alonb@clalit.org.il

eli sidon, MD

CONTACT

972-52-3896169elisid@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

April 19, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

April 19, 2011

Record last verified: 2011-03

Locations

IL(1)