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NCT Number: NCT05842395

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Prophylaxis Vitamine c Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin C

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 6, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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