Clinical trial NCT03665116: Effects of Dietary Supplement on Osteoarthritis
Official title: Effects of Arginine on Osteoarthritis: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Gene expression
Molecular phenotype
Osteoarthritis severity grading
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Ocean Frontier Institute
First posted: 2018-09-11
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effects arginine on osteoarthritis (OA) in adults. Participants will be randomly divided into two groups, taking arginine and nothing, respectively. Outcomes will be evaluated by lab test results on OA joint cartilage and self-administered questionnaires. The hypothesis is that arginine can slow down or reverse OA.

Detailed description: 1. Patients that meet the inclusion criteria will be approached by a member from their care team, details of this study will be explained. Verbal consent to screening will be obtained during this phone interview and recorded in the clinical trial database; patients will be screened for their eligibility, and a clinical visit will be arranged for eligible patients.
2. Consent form and questionnaires that are commonly used to collect general health information and assess OA patients' mental and physical functions (General Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 36-Item Short Form Health Survey (SF-36)) will be mailed to eligible patients. Patients will read consent form and fill up questionnaires.
3. Eligible patients will be reached by phone by the research assistant at a later date to obtain their verbal consent to further contact regarding participating in the study, and consent status will be recorded in the clinical trial database.
4. Initial clinical visit:

   1. All questions and concerns will be answered by researchers, consent form will be signed by participants, research assistant, and one of the investigators, and participants will be given a copy as record.
   2. Questionnaires (baseline) will be collected.
   3. 6.5 ml of blood sample (baseline) will be collected by a qualified research nurse.
   4. Participants will be randomly divided into 2 groups, each group will receive arginine and instruction or nothing, and will take arginine or nothing for 6 months:

      * Group I (n=50): 1.5 g of L-arginine daily.
      * Group II (n=50): No supplement.
5. Pre-admission clinical vist:

   * WOMAC and SF-36 questionnaires (at 6 months of the trial) will be administered.
   * 6.5 ml of blood sample (at 6 months of the trial) will be collected.
6. During total joint replacement surgery, small pieces of replaced joint cartilage tissue, which are normally thrown away, will be collected.
7. At 6 and 12 months after the surgery, participants will be reached via phone by the research assistant to complete WOMAC and SF-36 questionnaires. A blood requisition form will be mailed to participants after the last phone interview for their next scheduled routine fasting blood work; 4 ml of blood sample will be collected for the study and sent to the clinical trail lab by the blood collection centre.
8. Lab testing will be conducted; all outcome data will be obtained and analyzed.

Eligibility criteria: Inclusion Criteria:

* Undergoing total knee replacement surgery in 6 months due to primary knee OA
* Must be ambulatory
* Must live in 50 kilometers perimeter of St. John's, capital city of Newfoundland and Labrador, Canada

Exclusion Criteria:

* Clinical diagnosis of secondary OA or inflammatory arthritis
* Cod liver oil supplementation within 6 months
* Supplementation containing arginine within 6 months
* Osteoporotic fracture, previous knee surgery or arthroscopy within 6 months
* Use of bisphosphonates within 2 years
* Use of Intra-articular viscosupplementation or platelet rich plasma at any point

Primary outcomes:
measure: Target Gene Expressions in Osteoarthritic Knee Cartilage after 6 Months of Supplementation
timeFrame: up to 20 months
Secondary outcomes:
measure: OA Severity Grade of Osteoarthritic Knee Cartilage after 6 Months of Supplementation
timeFrame: up to 6 months
measure: WOMAC to Measure Changes in Joint Pain and Function between baseline and at 6 Months
timeFrame: at baseline and in 6 months
measure: WOMAC to Measure Changes in Joint Pain and Function between baseline and at 6 Months Post-surgery
timeFrame: at baseline and 6 months post-surgery
measure: WOMAC to Measure Changes in Joint Pain and Function between baseline and at 12 Months Post-surgery
timeFrame: at baseline and 12 months post-surgery
measure: SF-36 to Measure Changes in Physical and Mental Function between baseline and at 6 Months
timeFrame: at baseline and in 6 months
measure: SF-36 to Measure Changes in Physical and Mental Function between baseline and at 6 Months Post-surgery
timeFrame: at baseline and 6 months post-surgery
measure: SF-36 to Measure Changes in Physical and Mental Function between baseline and at 12 Months Post-surgery
timeFrame: at baseline and 12 months post-surgery
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Total Joint Assessment Clinic
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Guangju Zhai, PhD
role: PRINCIPAL_INVESTIGATOR
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