Osteoarthritis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPRN Joint Health Formula
DIETARY_SUPPLEMENTplacebo
DIETARY_SUPPLEMENTPRN Flex Omega Benefits® combination
Sponsors
Rothman Institute Orthopedics
Physician Recommended Nutriceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood | 12 weeks | 46 different markers of inaflammation will be studies |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12 weeks |
| Pain scores on Visual analog scale | 12 weeks |
Countries
United States
Outcome results
None listed