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

NCT00536302 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-06

No results posted yet for this study

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.

Conditions

  • Knee Osteoarthritis (OA)

Interventions

DIETARY_SUPPLEMENT

Collagen Hydrolysate

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

DIETARY_SUPPLEMENT

Placebo

Matching placebo solution per day by mouth for 48 weeks.

Sponsors & Collaborators

  • GELITA

    lead INDUSTRY

Principal Investigators

  • Timothy E McAlindon, MD, MPH · Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
49 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536302 on ClinicalTrials.gov