"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

NCT04204200 | Completed Results DMC

• 1 other identifier: CHHam
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Complex Regional Pain Syndrome I of Lower Limb

Outcome Measures

Primary Outcomes (4)

• Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity

  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

  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

  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

  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

Study Arms (3)

Allocated to conventional vitamin C (n= 22)

ACTIVE COMPARATOR

* Received allocated conventional vitamin C (n= 22) * Did not receive allocated conventional vitamin C (n= 0)

Dietary Supplement: standard vitamin C

Allocated to liposomal vitamin C (n= 22)

ACTIVE COMPARATOR

* Received allocated liposomal vitamin C (n= 22) * Did not receive allocated liposomal vitamin C (n= 0)

Dietary Supplement: liposomal vitamin C

Allocated to placebo (n= 22)

PLACEBO COMPARATOR

* Received allocated intervention (n= 22) * Did not receive allocated intervention (n= 0)

Dietary Supplement: placebo

Interventions

liposomal vitamin C DIETARY_SUPPLEMENT

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.

Allocated to liposomal vitamin C (n= 22)

standard vitamin C DIETARY_SUPPLEMENT

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).

Allocated to conventional vitamin C (n= 22)

placebo DIETARY_SUPPLEMENT

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).

Allocated to placebo (n= 22)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Ham: lead

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Results Point of Contact

• Title: Dr. Jean-Francois Cazeneuve, Surgeon
• Organization: Centre Hospitalier de Ham

jfc.laon@gmail.com

06 62 29 24 51

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon, MD

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: January 6, 2014
• Primary Completion: January 8, 2018
• Study Completion: June 19, 2019
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years
• Access Criteria: Information will be given after approval.