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

Sponsored by:	GELITA
Information provided by:	GELITA
ClinicalTrials.gov Identifier:	NCT00536302

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Dietary Supplements Diets Osteoarthritis

U.S. FDA Resources

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
1: Experimental Collagen Hydrolysate	Dietary Supplement: Collagen Hydrolysate Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
2: Placebo Comparator	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:	Tufts Medical Center ( Timothy E. McAlindon, MD, MPH - Principal Investigator )
Study ID Numbers:	Gelita TM 1
Study First Received:	September 26, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00536302 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GELITA:

OA
Knee arthritis
Osteoarthritis

Nutritional supplement
CAM
MRI

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009