A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA) (NMR)
This study has been completed.
Sponsor:
GELITA
Information provided by:
GELITA
ClinicalTrials.gov Identifier:
NCT00536302
First received: September 26, 2007
Last updated: February 5, 2009
Last verified: February 2009
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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
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 May 19, 2013