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Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01074476
Recruitment Status : Unknown
Verified June 2016 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : February 24, 2010
Last Update Posted : June 29, 2016
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
Osteoarthritis (OA) is the most common joint disease associated with aging. Although many patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the effectiveness of these supplements is questionable. This study will evaluate glucosamine therapy by directly analyzing two functions of joint fluid that are impaired by osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and analyzed on a device that simulates typical joint movements. After 3 months of glucosamine supplementation, samples will be collected again to detect potential improvements in joint fluid function.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Glucosamine sulphate Other: Placebo Not Applicable

Detailed Description:


The effectiveness of glucosamine sulphate as a treatment for OA is still under debate. Most clinical trials evaluate the effectiveness of OA treatments by self-administered questionnaires about joint pain, stiffness and function (Lequesne Algofunctional Index, Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC).

Although OA has been shown to reduce the viscosity and viscoelasticity of synovial fluid, few studies have used these properties as objective outcome measures in the assessment of glucosamine therapy.

The purpose of this study is to investigate whether glucosamine sulphate oral supplements improve the viscous and viscoelastic properties of synovial fluid in osteoarthritis patients and to explore potential correlations between these properties and subjective assessments of joint pain and function.

Research Method:

Patients will be invited to participate in the study if they have been recommended for synovial fluid aspiration to relieve joint discomfort caused by effusion. Subjects will be randomly assigned to receive either 1500mg of glucosamine sulphate or a placebo daily for 3 months. To relieve pain, subjects will be allowed to take up to 4000 mg of acetaminophen per day. If this is insufficient, NSAIDS will be permitted up to a maximum period of 5 consecutive days. Subjects will be asked to keep a log of their analgesics consumption.

At the baseline visit, patient demographics will be recorded and subjects will be asked to complete the WOMAC index questionnaire, which includes 24 questions to evaluate joint pain, stiffness and physical function. After noting the degree of joint effusion (minor, moderate, severe), an experienced physician will aspirate synovial fluid from the study knee to relieve joint pressure. A sample will be collected for analysis of viscosity and viscoelasticity.

Followup visits will be scheduled after every 4 weeks over the 3-month study period. Each visit will include the completion of a WOMAC questionnaire, clinical assessment of the degree of joint effusion and aspiration of synovial fluid (as necessary) for characterization. Any adverse events (such as headaches, abdominal pain, allergic episodes) will also be reported to the physician.

Changes in synovial fluid viscosity and viscoelasticity will be determined after 3 months of glucosamine supplementation and compared to the placebo group. Correlations between synovial fluid properties and WOMAC scores will also be described.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 1
Glucosamine sulphate tablets
Dietary Supplement: Glucosamine sulphate
750mg glucosamine sulphate (oral tablets), twice per day for 3 months

Placebo Comparator: 2
Placebo tablets
Other: Placebo
Placebo tablets, twice per day for 3 months

Primary Outcome Measures :
  1. Changes in synovial fluid viscosity and viscoelasticity compared to baseline [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are between 30 and 85 years of age
  • are clinically diagnosed with moderate to severe knee OA
  • are recommended for synovial fluid aspiration

Exclusion Criteria:

  • are clinically diagnosed with inflammatory arthritis
  • had previous joint surgery in the study knee
  • had injection in the study knee within the past 12 months
  • have taken glucosamine and/or chondroitin supplements within the past 3 months

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 identifier (NCT number): NCT01074476

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Canada, British Columbia
OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
University of British Columbia Health Clinic
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Ezra Kwok, Dr University of British Columbia
Study Director: Dana Grecov, Dr. University of British Columbia
Study Director: Christie Newton, Dr. University of British Columbia

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Responsible Party: University of British Columbia Identifier: NCT01074476    
Other Study ID Numbers: H10-00146
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Keywords provided by University of British Columbia:
Knee osteoarthritis
synovial fluid
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases