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

Sponsor

Damascus University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05842395

Collaborator

(none)

220

Enrollment

Location

Arms

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture Vitamine c Prophylaxis	Drug: Vitamin C Drug: Placebo	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

All participants and the consultants making definite treatment decisions and the researcher assistant collecting participants' data will be unaware of allocation until the completion of the study.

Primary Purpose:

Prevention

Official Title:

The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Vitamin C Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
Placebo Comparator: 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.	Drug: Placebo Participants with distal radius fractures will take daily Placebo orally for three months.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Vitamin C

Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.

Placebo Comparator: 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.

Drug: Placebo

Participants with distal radius fractures will take daily Placebo orally for three months.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damascus university	Damascus		Syrian Arab Republic

Sponsors and Collaborators

Damascus University

Investigators

Study Chair: jaber ibrahim, MD PHD, Damascus university - faculty of medicine - department of surgery
Study Director: hakam alasaad, MD, Damascus university - faculty of medicine - department of surgery
Principal Investigator: doried Diri, MD, Damascus university - faculty of medicine - department of surgery