NCT00296868

Brief Summary

Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in literature from 2 - 37%. The female sex is involved three times as much as the male sex. There is one study in literature which describes a prophylactic effect of vitamin C after wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and to replicate these earlier findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2001

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
Last Updated

February 27, 2006

Status Verified

December 1, 2005

First QC Date

February 24, 2006

Last Update Submit

February 24, 2006

Conditions

RSD (Reflex Sympathetic Dystrophy)AlgodystrophyCRPS Type I

Keywords

reflex sympathetic dystrophyascorbic acidprimary preventionradius fractures

Outcome Measures

Primary Outcomes (1)

  • the existence of CRPS until one year after follow-up

Secondary Outcomes (1)

  • difference in outcome and dose (dose comparison) after one year of follow-up

Interventions

ascorbic acid (vitamin C) versus placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • wrist fracture
  • adult (18 years and older)

You may not qualify if:

  • no comprehension of the written information
  • not able to appear for follow-up (living abroad)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rode Kruis Ziekenhuis, Vondellaan 13

Beverwijk, 1942 LE, Netherlands

Location

Related Publications (1)

  • Zollinger PE, Tuinebreijer WE, Kreis RW, Breederveld RS. Effect of vitamin C on frequency of reflex sympathetic dystrophy in wrist fractures: a randomised trial. Lancet. 1999 Dec 11;354(9195):2025-8. doi: 10.1016/S0140-6736(99)03059-7.

    PMID: 10636366RESULT

MeSH Terms

Conditions

Complex Regional Pain SyndromesReflex Sympathetic DystrophyRadius Fractures

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesForearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Paul E Zollinger, MD

    department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2005

Last Updated

February 27, 2006

Record last verified: 2005-12

Locations

NL(1)