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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis (OA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Collagen Hydrolysate

Group Type EXPERIMENTAL

Collagen Hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Matching placebo solution per day by mouth for 48 weeks.

Interventions

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Collagen Hydrolysate

Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Matching placebo solution per day by mouth for 48 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

49 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No