Recruiting

Phase 2

Vitamin CPerioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

Sponsor:

University Health Network, Toronto

Code:

NCT06123715

Conditions

Chronic Pain

Knee Pain Chronic

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin C

Placebo

Study Details

Brief summary:

Phase II Multicentre, pilot, parallel-group, blinded, 1:1 randomized controlled trial to determine the feasibility of conducting a larger definitive trail of using vitamin C to reduce persistent pain in patients undergoing total knee arthroplasty surgery.

Conditions

Chronic Pain

Knee Pain Chronic

Post Operative Pain

Study ID

NCT06123715

Start date

Apr 16, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients >18 years old
Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee

Exclusion Criteria:

TKA for infection (septic joint), fracture, ankylosing spondylitis, lupus, or psoriatic arthritis
History of kidney stones, acute or chronic renal failure, hemochromatosis, or glucose-6-phosphate deficiency
Unlikely to comply with follow-up (e.g., no fixed address, plans to move out of town)
Language difficulties that would impede valid completion of questionnaires
Planned staged bilateral TKA
Treating surgeon deems patient inappropriate for inclusion in trial
Any allergy or sensitivity to milk
Pregnant or planning to become pregnant during the study

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Preoperative Vitamin C capsules

placebo comparator: Placebo

Preoperative placebo capsules

Interventions

Vitamin C

Drug: Patients in the intervention group will receive 2g Vitamin C orally within 4 hours of the start of the surgery followed by 500 mg of Vitamin C to be taken orally twice a day from post-op day1 to day 56.

Placebo

Drug: Patients in the placebo group will receive identical placebo capsules taken orally within 4 hours of the start of the surgery followed by placebo capsules taken orally twice a day from post-op day 1 to day 56.

Primary outcome measure

Study will determine feasibility of enrolling, recruiting, and follow-up with patients. [ Time Frame: 12 months ]
Clinical site compliance [ Time Frame: 12 months ]
Resource Assessment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

James Khan, MD

416-340-4800 James.Khan@medportal.ca

Nour Ayach

(416) 340 4800 Nour.Ayach@uhn.ca

Locations

Sunnybrook - Holland Centre

Recruiting

Toronto, Ontario, Canada, M4Y 1H1

Contacts

Raman Mundi, MD

Raman.Mundi@medportal.ca

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

James Khan, MD

James.Khan@medportal.ca

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Anuj Bhatia, MD

Anuj.Bhatia@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-23.