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

October 22, 2023 updated by: Damascus University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic
        • Recruiting
        • Damascus University
        • Contact:
        • Principal Investigator:
          • Doried Diri, MD
        • Sub-Investigator:
          • Hakam Alasaad, MD
        • Sub-Investigator:
          • Hasan Ismail, MD
        • Sub-Investigator:
          • Sedra Mhana, MD
        • Sub-Investigator:
          • Jaber Ibrahim, MD pHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked 2 weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked 2 weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked four weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked four weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked six weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked six weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked eight weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked eight weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked twelve weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked twelve weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked sixteen weeks after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked sixteen weeks after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked six months after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked six months after definitive treatment.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Time Frame: checked twelve months after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
checked twelve months after definitive treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Orthopedics-5-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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