Effects of Dietary Supplement on Osteoarthritis

July 13, 2023 updated by: Guangju Zhai, PhD, Memorial University of Newfoundland

Effects of Arginine on Osteoarthritis: A Pilot Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3Z9
        • Total Joint Assessment Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arginine
L-arginine 1.5 g capsule by mouth, once daily for 6 months
Dietary supplement: L-arginine
L-arginine capsule
No Intervention: No Intervention
no supplement for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Gene Expressions in Osteoarthritic Knee Cartilage after 6 Months of Supplementation
Time Frame: up to 20 months
After participants have been taking arginine or nothing for 6 months, and cartilage tissue has been obtained during participants' total knee replacement surgery, target gene expressions in cartilage are measured with quantitative polymerase chain reaction (qPCR). Genes include cartilage degradation enzymes - matrix metallopeptidase 13 (MMP13), cathepsin K (CTSK), cathepsin B (CTSB), and cartilage syntheses genes - aggrecan (ACAN) and type II collagen (CTXII).
up to 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OA Severity Grade of Osteoarthritic Knee Cartilage after 6 Months of Supplementation
Time Frame: up to 6 months
After participants have been taking arginine or nothing for 6 months, and cartilage tissue has been obtained during participants' total knee replacement surgery, the Osteoarthritis Research Society International (OARSI) cartilage histopathology assessment protocol is used to grade OA severity of cartilage on a 7-point scale, with grade 0 as normal cartilage, 1 to 4 with articular cartilage changes only, and 5 to 6 involving subchondral bone.
up to 6 months
WOMAC to Measure Changes in Joint Pain and Function between baseline and at 6 Months
Time Frame: at baseline and in 6 months
WOMAC is used to collect data on participants' self reported joint pain intensity (5 items) and functional deficit (17 items) on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, and 0-68 for functional deficit, and total scores for joint pain and functional deficit at 6 months are compared to baseline, respectively.
at baseline and in 6 months
WOMAC to Measure Changes in Joint Pain and Function between baseline and at 6 Months Post-surgery
Time Frame: at baseline and 6 months post-surgery
WOMAC is used to collect data on participants' self reported joint pain intensity (5 items) and functional deficit (17 items) on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, and 0-68 for functional deficit, and total scores for joint pain and functional deficit at 6 months post surgery are compared to baseline, respectively.
at baseline and 6 months post-surgery
WOMAC to Measure Changes in Joint Pain and Function between baseline and at 12 Months Post-surgery
Time Frame: at baseline and 12 months post-surgery
WOMAC is used to collect data on participants' self reported joint pain intensity (5 items) and functional deficit (17 items) on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, and 0-68 for functional deficit, and total scores for joint pain and functional deficit at 12 months post surgery are compared to baseline, respectively.
at baseline and 12 months post-surgery
SF-36 to Measure Changes in Physical and Mental Function between baseline and at 6 Months
Time Frame: at baseline and in 6 months
SF-36 is used to collect data on self reported mental and physical health state on 8 scales: physical functioning (10 items); role limitations due to physical health (4 items); role limitations due to emotional problems (3 items); energy/fatigue (4 items); emotional well-being (5 items); social functioning (2 items); pain (2 items); general health (5 items); and self reported health change within one year. All 36 scores are recoded according to "Scoring Rules for the RAND 36-Item Health Survey (Version 1.0)", and items in the same scale are averaged together to generate 8 scale scores, each ranging between 0-100, with higher scores representing a more favorable health state. Scores at 6 months are compared to baseline.
at baseline and in 6 months
SF-36 to Measure Changes in Physical and Mental Function between baseline and at 6 Months Post-surgery
Time Frame: at baseline and 6 months post-surgery
SF-36 is used to collect data on self reported mental and physical health state on 8 scales: physical functioning (10 items); role limitations due to physical health (4 items); role limitations due to emotional problems (3 items); energy/fatigue (4 items); emotional well-being (5 items); social functioning (2 items); pain (2 items); general health (5 items); and self reported health change within one year. All 36 scores are recoded according to "Scoring Rules for the RAND 36-Item Health Survey (Version 1.0)", and items in the same scale are averaged together to generate 8 scale scores, each ranging between 0-100, with higher scores representing a more favorable health state. Scores at 6 months post-surgery are compared to baseline.
at baseline and 6 months post-surgery
SF-36 to Measure Changes in Physical and Mental Function between baseline and at 12 Months Post-surgery
Time Frame: at baseline and 12 months post-surgery
SF-36 is used to collect data on self reported mental and physical health state on 8 scales: physical functioning (10 items); role limitations due to physical health (4 items); role limitations due to emotional problems (3 items); energy/fatigue (4 items); emotional well-being (5 items); social functioning (2 items); pain (2 items); general health (5 items); and self reported health change within one year. All 36 scores are recoded according to "Scoring Rules for the RAND 36-Item Health Survey (Version 1.0)", and items in the same scale are averaged together to generate 8 scale scores, each ranging between 0-100, with higher scores representing a more favorable health state. Scores at 12 months post-surgery are compared to baseline.
at baseline and 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial University of Newfoundland

Collaborators

Ocean Frontier Institute

Investigators

  • Principal Investigator: Guangju Zhai, PhD, Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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