Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01074476
First received: February 22, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention
Knee Osteoarthritis
Dietary Supplement: Glucosamine sulphate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Changes in synovial fluid viscosity and viscoelasticity compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Background:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074476

Contacts
Contact: Ezra Kwok, Dr. 604.822.5431 ezra@chbe.ubc.ca

Locations
Canada, British Columbia
University of British Columbia Health Clinic Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Ezra Kwok, Dr.    604.822.5431    ezra@chbe.ubc.ca   
OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Ezra Kwok, Dr.    604.822.5431    ezra@chbe.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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
  More Information

Publications:

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01074476     History of Changes
Other Study ID Numbers: H10-00146
Study First Received: February 22, 2010
Last Updated: July 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Knee osteoarthritis
glucosamine
synovial fluid
viscosity
viscoelasticity
WOMAC

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

ClinicalTrials.gov processed this record on September 18, 2014