Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 2:38 AM
Study NCT ID:
NCT05842395
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
Sponsor:
Damascus University
Organization:
Study Overview
Official Title:
The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: