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

Primary Purpose

Distal Radius Fracture, Vitamine c, Prophylaxis

Status
Recruiting
Phase
Phase 4
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Distal Radius Fracture focused on measuring distal radius fractures, vitamine c, prophylaxis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Damascus UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Participants with distal radius fractures taking vitamin c supplementation.

Participants with distal radius fractures taking a placebo.

Arm Description

Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months.

Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.

Outcomes

Primary Outcome Measures

The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
October 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05842395
Brief Title
Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
Official Title
The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Vitamine c, Prophylaxis
Keywords
distal radius fractures, vitamine c, prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with distal radius fractures taking vitamin c supplementation.
Arm Type
Experimental
Arm Description
Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months.
Arm Title
Participants with distal radius fractures taking a placebo.
Arm Type
Placebo Comparator
Arm Description
Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants with distal radius fractures will take daily Placebo orally for three months.
Primary Outcome Measure Information:
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked 2 weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked four weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked six weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked eight weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked twelve weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked sixteen weeks after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked six months after definitive treatment.
Title
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
Description
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
Time Frame
checked twelve months after definitive treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jaber ibrahim, MD PHD
Phone
944411241
Ext
963
Email
drjaberhibrahim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jaber ibrahim, MD PHD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
hakam alasaad, MD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
doried Diri, MD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doried Diri, MD
Phone
967388095
Ext
963
Email
doried.diri@gmail.com
First Name & Middle Initial & Last Name & Degree
Doried Diri, MD
First Name & Middle Initial & Last Name & Degree
Hakam Alasaad, MD
First Name & Middle Initial & Last Name & Degree
Hasan Ismail, MD
First Name & Middle Initial & Last Name & Degree
Sedra Mhana, MD
First Name & Middle Initial & Last Name & Degree
Jaber Ibrahim, MD pHD

12. IPD Sharing Statement

Plan to Share IPD
No
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Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures

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