"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

January 31, 2020 updated by: Jean-François Cazeneuve, Centre Hospitalier de Ham

Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial

Abstract:

Complex regional pain syndrome (CRPS) is a significant complication in operated osteoarticular pathology and may adversely affect patient's quality of life. Vitamin C is an anti-oxidant and a neuro-modulating agent. Intake of vitamin C appears to be the only preventative factor. The objective of this study seeks to assess the effectiveness of liposomal conditioning of vitamin-C in reducing CRPS and to show evidence that it is more effective than taking vitamin C in its usual form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods:

Three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. The first group took vitamin C in liposomal form. The second one took classical vitamin C tablets while the third one received placebo pills. Comparison was made between both groups which were identical in number and were the same average age. Results were compared and analysed at the end of one-year follow-up.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, Age > 18 years
  • The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later)
  • Consenting patient
  • Agrees to maintain the current level of physical activity throughout the study.
  • Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study.
  • Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study
  • Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol.

Exclusion Criteria:

  • Pregnant, breastfeeding or considering pregnancy during the trial
  • Diabetic women
  • No renal lithiasis
  • No deficiency Glucose-6-phosphate dehydrogenase
  • Unstable medical conditions
  • Immunocompromised persons such as subjects who have undergone organ transplantation
  • Subjects who planned surgery during the clinical study
  • History of blood disorders / bleeding
  • Alcohol abuse (> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months
  • Participation in a clinical research trial within 30 days of randomization
  • Allergy or sensitivity to the product during the clinical study.
  • Persons who have a cognitive impairment and/or are unable to give an informed opinion.
  • Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Allocated to conventional vitamin C (n= 22)
  • Received allocated conventional vitamin C (n= 22)
  • Did not receive allocated conventional vitamin C (n= 0)
Dietary supplement: standard vitamin C
The intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
ACTIVE_COMPARATOR: Allocated to liposomal vitamin C (n= 22)
  • Received allocated liposomal vitamin C (n= 22)
  • Did not receive allocated liposomal vitamin C (n= 0)
Dietary supplement: liposomal vitamin C
The intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
PLACEBO_COMPARATOR: Allocated to placebo (n= 22)
  • Received allocated intervention (n= 22)
  • Did not receive allocated intervention (n= 0)
Dietary supplement: placebo
The intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity
Time Frame: After one-year of follow-up
We take an x-ray of the knee then we calculate of the Index of Caton and Deschamps AT / AP which must be close to 1 cm (from the upper edge to the lower edge of the patella which must be equal to the distance between the tip of the patella and anterior tibial tuberosity) to be interpreted as a transposed tuberosity.
After one-year of follow-up
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones
Time Frame: After one-year follow-up
Radiographs of the knee in monopodial support at 30° flexion (schuss) were taken. Measurement analysis of the translation of the tibia relative to the femur which must be close to 0 cm for the patient to be positive for the outcome.
After one-year follow-up
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis
Time Frame: After one-year follow-up
Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front
After one-year follow-up
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis
Time Frame: After one-year follow-up
X-rays of the knee and Schuss profile with an internal and external decoaptation which must be close to 0 cm with pan gonogram standing from the front (x-rays of the long axes of the pelvis of the ankles with measurement of the HKA axes on the prosthesis side and on the non-side operated which must be close to 180°) to have eccentric arthritis.
After one-year follow-up

Collaborators and Investigators

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

Sponsor

Centre Hospitalier de Ham

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)

January 6, 2014

Primary Completion (ACTUAL)

January 8, 2018

Study Completion (ACTUAL)

June 19, 2019

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHHam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

Information will be given after approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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