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Vitamin C for Postoperative Knee Pain (PROVISION Trial)

Phase 2

Recruiting

Led By Raman Mundi, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 12 months

Awards & highlights

PROVISION Trial Summary

This trial tests if vitamin C can reduce pain after knee surgery.

Who is the study for?

This trial is for adults over 18 who are having knee replacement surgery because of severe arthritis. It's not for those with knee replacements due to infection, fractures, certain autoimmune conditions, or if they're pregnant. Participants must be able to follow up and fill out questionnaires in the study language.Check my eligibility

What is being tested?

The study tests if Vitamin C can reduce long-term pain after knee replacement surgery compared to a placebo. It's a Phase II trial where participants are randomly assigned to either Vitamin C or placebo in equal numbers without knowing which one they receive.See study design

What are the potential side effects?

Vitamin C is generally safe but can sometimes cause side effects like stomach upset and kidney stones, especially at high doses. The risk may be higher for people with a history of kidney problems.

PROVISION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having knee replacement surgery due to severe arthritis.

PROVISION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical site compliance

Resource Assessment

Study will determine feasibility of enrolling, recruiting, and follow-up with patients.

Secondary outcome measures

Acute and chronic analgesic consumption

Adverse events

Development of Complex Regional Pain Syndrome (CRPS)

+8 more

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT03148236

10%

Pericarditis

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin C

Placebo

PROVISION Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Preoperative Vitamin C capsules

Group II: PlaceboPlacebo Group1 Intervention

Preoperative placebo capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin C

2017

Completed Phase 4

~18470

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,508 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,414 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,080 Total Patients Enrolled

3 Trials studying Postoperative Pain

400 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Intervention program gained official authorization from the FDA?

"Our internal evaluation rated the safety of Intervention to be a 2, as evidence exists in support of its security but not yet its efficiency."

Answered by AI

Are there open slots available for prospective participants in this research?

"Unfortunately, the trial outlined on clinicaltrials.gov is no longer recruiting patients; it was initially posted in January 2024 and last updated November 2023. Despite this, 961 other trials are actively seeking candidates right now."

Answered by AI

What positive results are researchers hopeful to achieve from this clinical trial?

"This trial will span 12 months and its main objective is Resource Assessment. However, other secondary metrics such as the Douleur Neuropathique 4 (DN4) symptoms interview for gauging Persistent Neuropathic Pain, the Oxford Knee Score (OKS) to measure physical function in relation to pain levels, and a 0-100 Patient Satisfaction scale are also going to be analyzed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

James Khan 2024. "Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06123715.