N/A N=66 Randomized Single-blind Prevention

"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

Complex Regional Pain Syndrome I of Lower Limb

Bottom Line

View on ClinicalTrials.gov: NCT04204200 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity — 1; 0; 2 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: liposomal vitamin C (Dietary_supplement); standard vitamin C (Dietary_supplement); placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Centre Hospitalier de Ham
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity	1; 0; 2	—
PRIMARY Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones	1; 0; 0	—
PRIMARY Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis	0; 0; 0	—
PRIMARY Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis	1; 0; 2	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04204200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.