A Placebo-Controlled Study of Collagen Hydrolysate in Sub... | NCT00536302

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

NCT00536302

Sponsor

GELITA

Status

Completed

Last Update Posted

Feb 6, 2009Estimated

Enrollment

30Actual

Phase

Phase 2Phase 3

Conditions

Knee Osteoarthritis (OA)

Interventions

Collagen Hydrolysate
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Sep 26, 2007

First Submission Date that Met QC Criteria

Sep 26, 2007

First Posted Date

Sep 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2009

Last Update Posted Date

Feb 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Collagen Hydrolysate	Dietary Supplement: Collagen Hydrolysate
2	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collagen Hydrolysate	Dietary Supplement	Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.		48 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

49 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy E McAlindon, MD, MPH	Tufts Medical Center; Center for Arthritis and Rheumatic Diseases	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases		Boston	Massachusetts	02111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28808182	Derived	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.

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases