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A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA) (NMR)

This study has been completed.
Sponsor:
Information provided by:
GELITA
ClinicalTrials.gov Identifier:
NCT00536302
First received: September 26, 2007
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.


Condition Intervention Phase
Knee Osteoarthritis (OA)
Dietary Supplement: Collagen Hydrolysate
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate

Resource links provided by NLM:


Further study details as provided by GELITA:

Primary Outcome Measures:
  • To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure knee cartilage volume over 48 weeks at three time points. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To measure and evaluate WOMAC pain subscale scores over 48 weeks. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To evaluate change in physical function tests over 48 weeks. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Collagen Hydrolysate
Dietary Supplement: Collagen Hydrolysate
Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
Placebo Comparator: 2 Dietary Supplement: Placebo
Matching placebo solution per day by mouth for 48 weeks.

Detailed Description:

This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.

  Eligibility

Ages Eligible for Study:   49 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 49 years
  • chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
  • WOMAC pain subscale score ≥ 1
  • tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
  • clinical examination confirming knee pain or discomfort referable to the knee joint
  • prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
  • stable medication and/or supplement use

Exclusion Criteria:

  • use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
  • serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
  • individuals who are expected not to comply with the study protocol
  • plan to permanently relocate from the region during the trial period
  • planned knee arthroplasty in the study knee
  • active pathology of confounding origin which may cause pain, extending to the knee
  • pregnancy
  • any contra-indication to having an MRI scan
  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: NCT00536302

Locations
United States, Massachusetts
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
GELITA
Investigators
Principal Investigator: Timothy E McAlindon, MD, MPH Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
  More Information

No publications provided

Responsible Party: Timothy E. McAlindon, MD, MPH - Principal Investigator, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00536302     History of Changes
Other Study ID Numbers: Gelita TM 1
Study First Received: September 26, 2007
Last Updated: February 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GELITA:
OA
Knee arthritis
Osteoarthritis
Nutritional supplement
CAM
MRI

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

ClinicalTrials.gov processed this record on November 25, 2014