Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT00536302
Status:
COMPLETED
Last Update Posted:
2009-02-06
First Post:
2007-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-05', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.', 'timeFrame': '48 Weeks'}], 'secondaryOutcomes': [{'measure': 'To measure knee cartilage volume over 48 weeks at three time points.', 'timeFrame': '48 Weeks'}, {'measure': 'To measure and evaluate WOMAC pain subscale scores over 48 weeks.', 'timeFrame': '48 Weeks'}, {'measure': 'To evaluate change in physical function tests over 48 weeks.', 'timeFrame': '48 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OA', 'Knee arthritis', 'Osteoarthritis', 'Nutritional supplement', 'CAM', 'MRI'], 'conditions': ['Knee Osteoarthritis (OA)']}, 'referencesModule': {'references': [{'pmid': '28808182', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '49 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 49 years\n* 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 ?"\n* WOMAC pain subscale score ≥ 1\n* 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\n* clinical examination confirming knee pain or discomfort referable to the knee joint\n* prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline\n* stable medication and/or supplement use\n\nExclusion Criteria:\n\n* use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization\n* serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial\n* individuals who are expected not to comply with the study protocol\n* plan to permanently relocate from the region during the trial period\n* planned knee arthroplasty in the study knee\n* active pathology of confounding origin which may cause pain, extending to the knee\n* pregnancy\n* any contra-indication to having an MRI scan'}, 'identificationModule': {'nctId': 'NCT00536302', 'acronym': 'NMR', 'briefTitle': 'A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GELITA'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Gelita TM 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Collagen Hydrolysate', 'interventionNames': ['Dietary Supplement: Collagen Hydrolysate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Collagen Hydrolysate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Matching placebo solution per day by mouth for 48 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center; Center for Arthritis and Rheumatic Diseases', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Timothy E McAlindon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center; Center for Arthritis and Rheumatic Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GELITA', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Timothy E. McAlindon, MD, MPH - Principal Investigator', 'oldOrganization': 'Tufts Medical Center'}}}}