NCT02333084

Brief Summary

This is a randomized, placebo controlled study. The first subject is expected to be enrolled in July 2014, and the last subject is expected to complete the study by July 2015. Each subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega Benefits® combination depending on randomization (1:1:1 at each site) during the course of the study. Instructions and frequency of use will be determined by the labelling.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

October 6, 2014

Last Update Submit

August 2, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood

    46 different markers of inaflammation will be studies

    12 weeks

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    12 weeks

  • Pain scores on Visual analog scale

    12 weeks

Study Arms (3)

Joint Health Product

EXPERIMENTAL

natural dietary supplement

Dietary Supplement: PRN Joint Health Formula

Placebo

PLACEBO COMPARATOR

vegetable oil placebo

Dietary Supplement: placebo

Combination with Omega-3

ACTIVE COMPARATOR

combination with omega-3 fish oil

Dietary Supplement: PRN Flex Omega Benefits® combination

Interventions

PRN Joint Health FormulaDIETARY_SUPPLEMENT
Joint Health Product
placeboDIETARY_SUPPLEMENT
Placebo
PRN Flex Omega Benefits® combinationDIETARY_SUPPLEMENT
Combination with Omega-3

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 and ≤ 90 at the time of informed consent.
  • Subjects with symptomatic moderate arthritis of the knee defined as per
  • Kellgren-Lawrence grade II or III (Appendix B). Subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study.
  • Ability to walk 50 feet unassisted.
  • Lequesne's Functional Index score greater than 7 points

You may not qualify if:

  • Subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others
  • Subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis.
  • Subjects taking hormone replacement therapy
  • Intra-articular corticosteroid injections 3 weeks prior to enrollment.
  • Hypersensitivity to fish oil.
  • Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, Hypertension (BP\>140/90), cancer and hyperkalemia.
  • Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders.
  • High alcohol intake (\>2 standard drinks per day). Pregnant, breastfeeding or planning to become pregnant during the study
  • Subjects awaiting surgery on the affected knee within three months.
  • Consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. Also, the regimen should not contain the same active compounds tested in the PRN Joint health formula product.
  • Vitamins/supplements cannot be introduced during a subject's participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Javad Parvizi, MD

    Rothman Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 6, 2014

First Posted

January 7, 2015

Study Start

July 1, 2014

Primary Completion

July 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

US(1)