Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
NCT ID: NCT05842395
Last Updated: 2024-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
220 participants
INTERVENTIONAL
2023-06-15
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?
NCT02216812
Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome
NCT06282640
Examination of the Pathophysiologic Mechanisms of CRPS by Using QST, CPM, RIC, and Heart Rate Variability QST
NCT02261012
The Investigation of Kinesiophobia in Conservative Distal Radius Fractures
NCT07291505
Dynasplint for Distal Radius Fracture
NCT01032356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with distal radius fractures taking vitamin c supplementation.
Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months.
Vitamin C
Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
Participants with distal radius fractures taking a placebo.
Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.
Placebo
Participants with distal radius fractures will take daily Placebo orally for three months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin C
Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
Placebo
Participants with distal radius fractures will take daily Placebo orally for three months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damascus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
jaber ibrahim, MD PHD
Role: STUDY_CHAIR
Damascus university - faculty of medicine - department of surgery
hakam alasaad, MD
Role: STUDY_DIRECTOR
Damascus university - faculty of medicine - department of surgery
doried Diri, MD
Role: PRINCIPAL_INVESTIGATOR
Damascus university - faculty of medicine - department of surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Damascus University
Damascus, , Syria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sandroni 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.
Beerthuizen 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.
Besse 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.
van 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.
Cummings 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.
Owen 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.
Colles 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.
Ilyas 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.
Muller 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.
Bushnell 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.
Mathews 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.
Zyluk 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.
Goris 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.
Oaklander AL, Rissmiller JG, Gelman LB, Zheng L, Chang Y, Gott R. Evidence of focal small-fiber axonal degeneration in complex regional pain syndrome-I (reflex sympathetic dystrophy). Pain. 2006 Feb;120(3):235-243. doi: 10.1016/j.pain.2005.09.036. Epub 2006 Jan 19.
Bruehl S, Harden RN, Galer BS, Saltz S, Backonja M, Stanton-Hicks M. Complex regional pain syndrome: are there distinct subtypes and sequential stages of the syndrome? Pain. 2002 Jan;95(1-2):119-24. doi: 10.1016/s0304-3959(01)00387-6.
Zyluk A. [Chronic, refractory algodystrophy]. Chir Narzadow Ruchu Ortop Pol. 2006;71(6):439-46. Polish.
Puchalski P, Zyluk A. Complex regional pain syndrome type 1 after fractures of the distal radius: a prospective study of the role of psychological factors. J Hand Surg Br. 2005 Dec;30(6):574-80. doi: 10.1016/j.jhsb.2005.06.023. Epub 2005 Aug 29.
Perez MRSG, Zuurmond AWW, Bezemer DP, Kuik JD, van Loenen CA, de Lange JJ, Zuidhof JA. The treatment of complex regional pain syndrome type I with free radical scavengers: a randomized controlled study. Pain. 2003 Apr;102(3):297-307. doi: 10.1016/S0304-3959(02)00414-1.
Zyluk A, Puchalski P. Treatment of early complex regional pain syndrome type 1 by a combination of mannitol and dexamethasone. J Hand Surg Eur Vol. 2008 Apr;33(2):130-6. doi: 10.1177/1753193408087034.
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.
Abdullah M, Jamil RT, Attia FN. Vitamin C (Ascorbic Acid). 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499877/
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UDMS-Orthopedics-5-2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.