Ankle FractureCRPSNCT01338129
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
A study testing vitamin c in people with Ankle Fracture, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- vitamin c
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ankle fracture within 3 weeks after the fracture
Who cannot join
- pregnant or lactating woman
- open fracture
- already treated with vitamin c
- chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)
Read the detailed description
There are several studies similar in wrist fracture.
- Conditions
- Ankle Fracture
- Being tested
- vitamin c, placebo
- Keywords
- vitamin c, ascorbic acid, ankle fracture, crps, rds, crps prevention
- Medical subject headings
- Ankle Fractures, Complex Regional Pain Syndromes, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin cDietary supplement
Also called ascorbic acid
1000 mg of vitamin c for 45 days
placeboDrug
placebo pills
| Study group | Role | What they receive |
|---|---|---|
| vitamin c | Experimental | administration of vitamin c for 45 days following ankle fracture operation Receives: Dietary Supplement: vitamin c |
| placebo | Placebo comparator | placebo pills Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338129
- Sponsor's protocol ID
- RMC116131CTIL
- Acronym
- CRPS
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study
- ClinicalTrials.gov ID
- NCT01338129
- Acronym / sponsor ID
- CRPS / RMC116131CTIL
- Conditions
- Ankle Fracture
- Keywords
- vitamin c, ascorbic acid, ankle fracture, crps, rds, crps prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin c | Experimental | Dietary Supplement: vitamin cadministration of vitamin c for 45 days following ankle fracture operation |
| placebo | Placebo comparator | Drug: placeboplacebo pills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ankle fracture within 3 weeks after the fracture
Key exclusion criteria (4 listed)
- pregnant or lactating woman
- open fracture
- already treated with vitamin c
- chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin cAlso: ascorbic acid1000 mg of vitamin c for 45 days | Dietary supplement | vitamin c |
| placeboplacebo pills | Drug | placebo |
Primary outcome
CRPS incidence
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin c in people with Ankle Fracture, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alon burg, MD (972-54-4854248, alonb@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRPS incidence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.