Distal Radius FracturePhase 4NCT05842395
Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
A Phase 4 study testing Vitamin C in people with Distal Radius Fracture and Vitamine c, run by Damascus University at 1 site in Syria.
Trial summary
Complex Regional Pain Syndrome type 1 is a pain syndrome that develops after a trauma, surgery, or idiopathically. The incidence after distal radius varies significantly in the literature. There are known contributing factors, such as the female sex but no effective treatment or prophylactic method. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Vitamine c, Prophylaxis
- 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
- 220 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jun 2023to 15 Mar 2025
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants who were injured with distal radius fractures and classified using the AO classification as A1, A2, A3, B1, and C1.
Who cannot join
- Multiple trauma patients.
- patients who have neurovascular injuries.
- Patients with fractures are classified using the AO classification as B2, B3, C2, and C3.
- Patients who are eligible for open reduction internal fixation of their fractures.
- Patients with chronic or acute renal failure.
- Patients who already take multi-vitamin supplementation or vitamin C supplementation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study
Complex Regional Pain Syndrome type 1 is a pain syndrome that develops after a trauma, surgery, or idiopathically. The incidence after distal radius varies significantly in the literature. There are known contributing factors, such as the female sex but no effective treatment or prophylactic method. This study aims to investigate vitamin C's efficacy in preventing CRPS type 1 following distal radius fractures, as the literature states that it might play a role in prophylaxis.
Read the detailed description
Complex regional pain syndrome is the most challenging complication to overcome following distal radius fractures. The precise etiology still needs to be fully understood. It is thought that ways of prevention could be the most effective way of managing this dilemma, as no effective treatment is yet to be found.
One of the ways of prevention is vitamin C supplementation, as it is thought that the toxic oxygen radicals play a significant role in the inflammatory process that ultimately manifests as CRPS. Vitamin C, as an antioxidant, could play a role in stopping this process.
The theoretical background of this research is that CRPS commonly occurs following distal radius fractures, and vitamin C supplementation could play a role in prophylaxis. To assess that, the investigator is conducting a randomized controlled trial.
The trial is designed as a multicenter, randomized, controlled study. Two hospitals in Syria, Damascus, participated in this study using the same experimental design.
Adults (18 years or above) with distal radius fractures who will be seen in the emergency department of each hospital will be asked to participate in this study. Patients will be asked to start the trial medication on the day of the fracture following the suitable treatment method chosen by the orthopedics consultant in each hospital. Capsules had to be taken once daily for 90 days. Patients will be allocated randomly to receive either a placebo or 1g of vitamin C daily.
The study's endpoint will be defined as the presence of CRPS at any moment up to one year after the fracture. All participants and physicians will be unaware of the treatment allocation.
The diagnosis will be built upon the Budapest criteria, which will be checked in every follow-up for one year.
Patients will be seen after two weeks, four weeks (or when the cast was removed), six weeks, 12 weeks, six months, and 12 months. The protocol will not compromise the adequate fracture treatment, either conservative or operative, by closed reduction and percutaneous pinning. If necessary, patients will be seen more often and at other times than planned.
- Conditions
- Distal Radius Fracture, Vitamine c, Prophylaxis
- Being tested
- Vitamin C, Placebo
- Keywords
- distal radius fractures, vitamine c, prophylaxis
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
PlaceboDrug
Participants with distal radius fractures will take daily Placebo orally for three months.
| Study group | Role | What they receive |
|---|---|---|
| Participants with distal radius fractures taking vitamin c supplementation. | Experimental | Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months. Receives: Drug: Vitamin C |
| Participants with distal radius fractures taking a placebo. | Placebo comparator | Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked 2 weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked four weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked six weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked eight weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked twelve weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked sixteen weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked six months after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Measured: checked twelve months after definitive treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Jun 2023
- Primary completion30 May 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Distal Radius 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jaber ibrahim, MD PHD, Study chair, Damascus university - faculty of medicine - department of surgeryhakam alasaad, MD, Study director, Damascus university - faculty of medicine - department of surgerydoried Diri, MD, Principal investigator, Damascus university - faculty of medicine - department of surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842395
- Sponsor's protocol ID
- UDMS-Orthopedics-5-2023
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pogue DJ, Viegas SF, Patterson RM, Peterson PD, Jenkins DK, Sweo TD, Hokanson JA. Effects of distal radius fracture malunion on wrist joint mechanics. J Hand Surg Am. 1990 Sep;15(5):721-7. doi: 10.1016/0363-5023(90)90143-f.
PubMed 2229966Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4.
PubMed 12749974Beerthuizen A, Stronks DL, Van't Spijker A, Yaksh A, Hanraets BM, Klein J, Huygen FJPM. Demographic and medical parameters in the development of complex regional pain syndrome type 1 (CRPS1): prospective study on 596 patients with a fracture. Pain. 2012 Jun;153(6):1187-1192. doi: 10.1016/j.pain.2012.01.026. Epub 2012 Mar 3.
PubMed 22386473Besse JL, Gadeyne S, Galand-Desme S, Lerat JL, Moyen B. Effect of vitamin C on prevention of complex regional pain syndrome type I in foot and ankle surgery. Foot Ankle Surg. 2009;15(4):179-82. doi: 10.1016/j.fas.2009.02.002. Epub 2009 Apr 5.
PubMed 19840748van der Laan L, Kapitein PJ, Oyen WJ, Verhofstad AA, Hendriks T, Goris RJ. A novel animal model to evaluate oxygen derived free radical damage in soft tissue. Free Radic Res. 1997 Apr;26(4):363-72. doi: 10.3109/10715769709097816.
PubMed 9167941Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. doi: 10.1093/oxfordjournals.epirev.a036281. No abstract available.
PubMed 3902494Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605.
PubMed 7072880Colles A. On the Fracture of the Carpal Extremity of the Radius. Edinb Med Surg J. 1814 Apr 1;10(38):182-186. No abstract available.
PubMed 30329360Ilyas AM, Jupiter JB. Distal radius fractures--classification of treatment and indications for surgery. Orthop Clin North Am. 2007 Apr;38(2):167-73, v. doi: 10.1016/j.ocl.2007.01.002.
PubMed 17560399Muller ME, Nazarian S, Koch PP. Classification AO des fractures. springer; 1987.
McKay SD, MacDermid JC, Roth JH, Richards RS. Assessment of complications of distal radius fractures and development of a complication checklist. J Hand Surg Am. 2001 Sep;26(5):916-22. doi: 10.1053/jhsu.2001.26662.
PubMed 11561246Bushnell BD, Bynum DK. Malunion of the distal radius. J Am Acad Orthop Surg. 2007 Jan;15(1):27-40. doi: 10.5435/00124635-200701000-00004.
PubMed 17213380Mathews AL, Chung KC. Management of complications of distal radius fractures. Hand Clin. 2015 May;31(2):205-15. doi: 10.1016/j.hcl.2014.12.002. Epub 2015 Feb 28.
PubMed 25934197Zyluk A, Puchalski P. Complex regional pain syndrome of the upper limb: a review. Neurol Neurochir Pol. 2014;48(3):200-5. doi: 10.1016/j.pjnns.2014.05.007. Epub 2014 Jun 6.
PubMed 24981185Goris RJ, Dongen LM, Winters HA. Are toxic oxygen radicals involved in the pathogenesis of reflex sympathetic dystrophy? Free Radic Res Commun. 1987;3(1-5):13-8. doi: 10.3109/10715768709069764.
PubMed 3508426
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT05842395
- Acronym / sponsor ID
- UDMS-Orthopedics-5-2023
- Conditions
- Distal Radius Fracture, Vitamine c, Prophylaxis
- Keywords
- distal radius fractures, vitamine c, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 6 May 2023 (actual)
- 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.
Complex Regional Pain Syndrome type 1 is a pain syndrome that develops after a trauma, surgery, or idiopathically. The incidence after distal radius varies significantly in the literature. There are known contributing factors, such as the female sex but no effective treatment or prophylactic method. This study aims to investigate vitamin C's efficacy in preventing CRPS type 1 following distal radius fractures, as the literature states that it might play a role in prophylaxis.
Detailed description
Complex regional pain syndrome is the most challenging complication to overcome following distal radius fractures. The precise etiology still needs to be fully understood. It is thought that ways of prevention could be the most effective way of managing this dilemma, as no effective treatment is yet to be found.
One of the ways of prevention is vitamin C supplementation, as it is thought that the toxic oxygen radicals play a significant role in the inflammatory process that ultimately manifests as CRPS. Vitamin C, as an antioxidant, could play a role in stopping this process.
The theoretical background of this research is that CRPS commonly occurs following distal radius fractures, and vitamin C supplementation could play a role in prophylaxis. To assess that, the investigator is conducting a randomized controlled trial.
The trial is designed as a multicenter, randomized, controlled study. Two hospitals in Syria, Damascus, participated in this study using the same experimental design.
Adults (18 years or above) with distal radius fractures who will be seen in the emergency department of each hospital will be asked to participate in this study. Patients will be asked to start the trial medication on the day of the fracture following the suitable treatment method chosen by the orthopedics consultant in each hospital. Capsules had to be taken once daily for 90 days. Patients will be allocated randomly to receive either a placebo or 1g of vitamin C daily.
The study's endpoint will be defined as the presence of CRPS at any moment up to one year after the fracture. All participants and physicians will be unaware of the treatment allocation.
The diagnosis will be built upon the Budapest criteria, which will be checked in every follow-up for one year.
Patients will be seen after two weeks, four weeks (or when the cast was removed), six weeks, 12 weeks, six months, and 12 months. The protocol will not compromise the adequate fracture treatment, either conservative or operative, by closed reduction and percutaneous pinning. If necessary, patients will be seen more often and at other times than planned.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with distal radius fractures taking vitamin c supplementation. | Experimental | Drug: Vitamin CParticipants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months. |
| Participants with distal radius fractures taking a placebo. | Placebo comparator | Drug: PlaceboParticipants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants who were injured with distal radius fractures and classified using the AO classification as A1, A2, A3, B1, and C1.
Key exclusion criteria (6 listed)
- Multiple trauma patients.
- patients who have neurovascular injuries.
- Patients with fractures are classified using the AO classification as B2, B3, C2, and C3.
- Patients who are eligible for open reduction internal fixation of their fractures.
- Patients with chronic or acute 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 CParticipants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months. | Drug | Participants with distal radius fractures taking vitamin c supplementation. |
| PlaceboParticipants with distal radius fractures will take daily Placebo orally for three months. | Drug | Participants with distal radius fractures taking a placebo. |
Primary outcome
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked 2 weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked four weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked six weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked eight weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked twelve weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked sixteen weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked six months after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time frame: checked twelve months after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 2229966Pogue DJ, Viegas SF, Patterson RM, Peterson PD, Jenkins DK, Sweo TD, Hokanson JA. Effects of distal radius fracture malunion on wrist joint mechanics. J Hand Surg Am. 1990 Sep;15(5):721-7. doi: 10.1016/0363-5023(90)90143-f.
- Background: PubMed 12749974Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4.
- Background: PubMed 22386473Beerthuizen A, Stronks DL, Van't Spijker A, Yaksh A, Hanraets BM, Klein J, Huygen FJPM. Demographic and medical parameters in the development of complex regional pain syndrome type 1 (CRPS1): prospective study on 596 patients with a fracture. Pain. 2012 Jun;153(6):1187-1192. doi: 10.1016/j.pain.2012.01.026. Epub 2012 Mar 3.
- Background: PubMed 19840748Besse JL, Gadeyne S, Galand-Desme S, Lerat JL, Moyen B. Effect of vitamin C on prevention of complex regional pain syndrome type I in foot and ankle surgery. Foot Ankle Surg. 2009;15(4):179-82. doi: 10.1016/j.fas.2009.02.002. Epub 2009 Apr 5.
- Background: PubMed 9167941van der Laan L, Kapitein PJ, Oyen WJ, Verhofstad AA, Hendriks T, Goris RJ. A novel animal model to evaluate oxygen derived free radical damage in soft tissue. Free Radic Res. 1997 Apr;26(4):363-72. doi: 10.3109/10715769709097816.
- Background: PubMed 3902494Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. doi: 10.1093/oxfordjournals.epirev.a036281. No abstract available.
- Background: PubMed 7072880Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605.
- Background: PubMed 30329360Colles A. On the Fracture of the Carpal Extremity of the Radius. Edinb Med Surg J. 1814 Apr 1;10(38):182-186. No abstract available.
- Background: PubMed 17560399Ilyas AM, Jupiter JB. Distal radius fractures--classification of treatment and indications for surgery. Orthop Clin North Am. 2007 Apr;38(2):167-73, v. doi: 10.1016/j.ocl.2007.01.002.
- BackgroundMuller ME, Nazarian S, Koch PP. Classification AO des fractures. springer; 1987.
- Background: PubMed 11561246McKay SD, MacDermid JC, Roth JH, Richards RS. Assessment of complications of distal radius fractures and development of a complication checklist. J Hand Surg Am. 2001 Sep;26(5):916-22. doi: 10.1053/jhsu.2001.26662.
- Background: PubMed 17213380Bushnell BD, Bynum DK. Malunion of the distal radius. J Am Acad Orthop Surg. 2007 Jan;15(1):27-40. doi: 10.5435/00124635-200701000-00004.
- Individual participant dataSharing planned: No
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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.
jaber ibrahim, MD PHD study chair
Damascus university - faculty of medicine - department of surgery
hakam alasaad, MD study director
Damascus university - faculty of medicine - department of surgery
doried Diri, MD principal investigator
Damascus university - faculty of medicine - department of surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin C in people with Distal Radius Fracture and Vitamine c, run by Damascus University at 1 site in Syria.
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 6 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: finished, as of the sponsor's last update on 19 Mar 2026. 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 Syria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS. (time frame: checked 2 weeks after definitive treatment.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842395, which also lists 23 linked publications.
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 Mar 2026.