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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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Damascus University
Damascus, Syria
Start Date
June 15, 2023
Primary Completion Date
May 30, 2024
Completion Date
March 15, 2025
Last Updated
March 19, 2026
220
ACTUAL participants
Vitamin C
DRUG
Placebo
DRUG
Lead Sponsor
Damascus University
NCT07071623
NCT05650996
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07294547