"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

Not Applicable

Completed

• Conditions: Complex Regional Pain Syndrome I of Lower Limb
• Interventions: Dietary Supplement: standard vitamin C; Dietary Supplement: liposomal vitamin C; Dietary Supplement: placebo

• Registration Number: NCT04204200
• Lead Sponsor: Centre Hospitalier de Ham

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.

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 Timeline

• Study Start: 2014-01-06
• Primary Completion: 2018-01-08
• Study Completion: 2019-06-19
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Results First Submitted: 2019-12-20
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Results First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allocated to conventional vitamin C (n= 22)	standard vitamin C	* Received allocated conventional vitamin C (n= 22) * Did not receive allocated conventional vitamin C (n= 0)
Allocated to liposomal vitamin C (n= 22)	liposomal vitamin C	* Received allocated liposomal vitamin C (n= 22) * Did not receive allocated liposomal vitamin C (n= 0)
Allocated to placebo (n= 22)	placebo	* Received allocated intervention (n= 22) * Did not receive allocated intervention (n= 0)

Primary Outcome Measures

Name	Time	Method
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones	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.
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis	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
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity	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.
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis	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.