NCT00536302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

1.7 years

First QC Date

September 26, 2007

Last Update Submit

February 5, 2009

Conditions

Knee Osteoarthritis (OA)

Keywords

OAKnee arthritisOsteoarthritisNutritional supplementCAMMRI

Outcome Measures

Primary Outcomes (1)

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

    48 Weeks

Secondary Outcomes (3)

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

    48 Weeks

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

    48 Weeks

  • To evaluate change in physical function tests over 48 weeks.

    48 Weeks

Study Arms (2)

1

EXPERIMENTAL

Collagen Hydrolysate

Dietary Supplement: Collagen Hydrolysate

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Collagen HydrolysateDIETARY_SUPPLEMENT

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

1
PlaceboDIETARY_SUPPLEMENT

Matching placebo solution per day by mouth for 48 weeks.

2

Eligibility Criteria

Age49 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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.

    PMID: 28808182DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Timothy E McAlindon, MD, MPH

    Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

US(1)