Nutramax Joint Health Formulation Biochemical Response Study

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

The Nutramax test article is a nutritional supplement that contains several ingredients shown to potentially provide benefit to patients suffering from a painful and sometimes debilitating condition of the knee called "osteoarthritis." This is a pilot study that is intended to determine whether results from a proprietary testing panel conducted on blood and urine samples will correlate with data from physical examination and validated surveys that measure participants' quality of life and physical capabilities.

Key facts

Study ID: NCT02614274
Run by: University of Missouri-Columbia
People needed: 9
Starts: 2014-11-01
Expected to finish: 2016-01-01
Last updated by the study team: 2018-11-05

Who can join

Age: 40 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subject is able to understand and sign the informed consent.
Subject is willing and able to comply with the protocol.
Male or female subjects of any race, aged 40 to 64 years
Subject has a BMI of 24 to 40 kg/m2
Subject has had pain in one or both knees for a minimum of 15 days within the 30 days prior to the start of the study.
Subject has had symptoms of knee pain for at least 6 months.
Subject has been diagnosed within the previous 30 days with moderate to severe knee osteoarthritis - based on attending physician's diagnosis from physical exam in conjunction with Kellgren-Lawrence X-ray grade of ≥ 2 (radiographs taken within previous 30 days must be available to the investigator, or be obtained at the screening visit).
Subject can walk.
Before study enrollment, subject routinely uses acetaminophen (at any dose) with a history of therapeutic benefit.
Subject has a visual analogue scale (VAS) score of ≥ 4 at the initial visit. Subject may continue taking acetaminophen at the screening but will not have taken additional analgesics for at least 48 hours prior to the initial visit.
Female subject abstains from sexual intercourse, is surgically sterile, post-menopausal, or agrees to use a FDA-approved method of birth control.

You may not qualify if…

Subject has any of the following medical conditions:
active heart disease - defined as currently under the care of a cardiologist
high blood pressure (≥ 140/90 mmHg)
renal or hepatic impairment/disease
Type I or II diabetes
Bipolar or major depressive disorder or a history of other psychiatric illness requiring hospitalization in the past 6 months.
Parkinson's disease
unstable thyroid disease
immune disorder (such as HIV/AIDS)
multiple sclerosis or any other autoimmune disorder
any arthritic condition, other than OA, affecting a joint other than the knee
acute septic arthritis
fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
gout and hyperuricemia
peptic ulcer disease and/or history of upper gastrointestinal bleeding
any medical condition deemed exclusionary by the Principal Investigator (PI)
Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
Subject has had a significant injury to the target joint within the past 12 months.
Subject plans to have knee surgery in the next 2 months.
Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the test product.
Subject requires additional analgesic or a change from acetaminophen. (Subjects requiring acetaminophen dose adjustments may remain in the study and all such dose and/or schedule changes shall be recorded in the raw data and daily patient diary).
Subject is currently taking any medication or suffers from a medical condition, deemed to potentially interfere with the objectives of the study as determined by the PI.
Subject has a history of drug or alcohol abuse in the past 12 months.
Subject is currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.

Where it is running

University of Missouri, Missouri Orthopaedic Institute — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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