Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures

Phase 4

Recruiting

• Conditions: Distal Radius Fracture; Prophylaxis; Vitamine c
• Interventions: Drug: Vitamin C; Drug: Placebo

• Registration Number: NCT05842395
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-06-15
• Status Verified: 2024-05
• Primary Completion: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• participants who were injured with distal radius fractures and classified using the AO classification as A1, A2, A3, B1, and C1.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with distal radius fractures taking vitamin c supplementation.	Vitamin C	Participants 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	Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.

Primary Outcome Measures

Name	Time	Method
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	checked twelve months after definitive treatment.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic