Back to results

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

Primary Purpose

Knee Osteoarthritis (OA)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Collagen Hydrolysate

Placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis (OA) focused on measuring OA, Knee arthritis, Osteoarthritis, Nutritional supplement, CAM, MRI

Eligibility Criteria

49 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Collagen Hydrolysate

Outcomes

Primary Outcome Measures

To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.

Secondary Outcome Measures

To measure knee cartilage volume over 48 weeks at three time points.

To measure and evaluate WOMAC pain subscale scores over 48 weeks.

To evaluate change in physical function tests over 48 weeks.

Full Information

NCT ID

NCT00536302

First Posted

September 26, 2007

Last Updated

February 5, 2009

Sponsor

GELITA

1. Study Identification

Unique Protocol Identification Number

NCT00536302

Brief Title

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

Acronym

NMR

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GELITA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis (OA)

Keywords

OA, Knee arthritis, Osteoarthritis, Nutritional supplement, CAM, MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Collagen Hydrolysate

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Collagen Hydrolysate

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Matching placebo solution per day by mouth for 48 weeks.

Primary Outcome Measure Information:

Title

To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.

Time Frame

48 Weeks

Secondary Outcome Measure Information:

Title

To measure knee cartilage volume over 48 weeks at three time points.

Time Frame

48 Weeks

Title

To measure and evaluate WOMAC pain subscale scores over 48 weeks.

Time Frame

48 Weeks

Title

To evaluate change in physical function tests over 48 weeks.

Time Frame

48 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

49 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy E McAlindon, MD, MPH

Organizational Affiliation

Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28808182

Citation

McAlindon T, Bartnik E, S Ried J, Teichert L, Herrmann M, Flechsenhar K. Determination of serum biomarkers in osteoarthritis patients: a previous interventional imaging study revisited. J Biomed Res. 2016 Oct 17;31(1):25-30. doi: 10.7555/JBR.31.20150167.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs