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Effects of Dietary Supplement on Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03665116
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Ocean Frontier Institute
Information provided by (Responsible Party):
Guangju Zhai, PhD, Memorial University of Newfoundland

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: L-arginine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Arginine on Osteoarthritis: A Pilot Clinical Trial
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665116


Contacts
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Contact: Guangju Zhai, PhD 709-864-6683 guangju.zhai@med.mun.ca

Locations
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Canada, Newfoundland and Labrador
Total Joint Assessment Clinic Recruiting
St. John's, Newfoundland and Labrador, Canada, A1A 3Z9
Contact: Michelle Alexander, BSW; RSW    709-777-1320    michelle.alexander@easternhealth.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Ocean Frontier Institute
Investigators
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Principal Investigator: Guangju Zhai, PhD Memorial University of Newfoundland

Publications:

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Responsible Party: Guangju Zhai, PhD, Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03665116     History of Changes
Other Study ID Numbers: 20190018
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guangju Zhai, PhD, Memorial University of Newfoundland:
Gene expression
Molecular phenotype
Osteoarthritis severity grading

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases