Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee (11SOHS)

KGK Science

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis of the Knee

Treatments

Dietary Supplement: Placebo

Dietary Supplement: SierraSil Joint Formula 14

Study type

Interventional

Funder types

Industry

Identifiers

NCT02156440

11SOHS

Details and patient eligibility

About

Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises the quality of life of more than 21 million North Americans. Studies on the use of complimentary and alternative medicines have reported that OA patients in the US are among the highest users of CAM. Previous studies on a unique natural mineral product SierraSil® demonstrated an improvement in joint health and function in subjects with mild to moderate OA of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in response to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated events in human cartilage. The primary objective is to assess the efficacy of SeirraSil Joint Formula versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™ Osteoarthritis Index Pain subscale in subjects with osteoarthritis of the knee.

Enrollment

150 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female 18-65 years of age
If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Intrauterine devices
Vasectomy of partner (shown successful as per appropriate follow-up)
Abstinence
Primary or secondary, unilateral or bilateral osteoarthritis of the knee (American College of Rheumatology Clinical Criteria for Classification)

Knee pain with at least 3 of the following:

Age > 50 years
Stiffness < 30 minutes
Crepitus
Bony Tenderness
Bony enlargement
No palpable warmth
Self reported difficulty performing at least one of the following activities because of knee pain:
lifting and carrying groceries
walking one-quarter of a mile
getting in and out of a chair
going up and down stairs
mobility
self-care activities
Able to walk unassisted (may use walking stick, crutch, or knee brace)
Availability for duration of study period (14 weeks)
Subject using other therapies for OA, such as exercise, heat/cold therapy, joint protection and physiotherapy/occupational therapy agrees to continue these therapies as normal avoiding changes in frequency or intensity and to record therapies in the study diary
Subject agrees not to start any new therapies for OA during the course of the study
Has given voluntary, written, informed consent to participate in the study

Exclusion criteria

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, spinal disorders or other musculoskeletal disease
Subject has been recommended for knee surgery
Subject has hemosiderosis or hemochromatosis
Subject has kidney or liver disease, blood disorders, active cancer and/or HIV infection
Subject has significant medical history or current metabolic disorders, thyroid disease, immune disorders and/or cardiovascular disease will be reviewed by the Qualified Investigator (QI). Subjects deemed by the QI to be at possible risk will not be permitted in this study.
Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
Planned surgery during the course of the trial
Use of intra-articular, oral or parenteral corticosteroids, or other injectable prescription medication (e.g., Synvisc) within 2 months prior to randomization and during the trial
Requires the use of prescription drugs to control pain (other than provided rescue medication)
Use of oral or topical prescription or over the counter medications or natural health products for pain relief 48 hours prior to randomization and during the trial (other than provided rescue medication)
Use of iron supplementation during the trial (i.e. provided by multivitamins, prescription medication, or any other mineral preparations containing iron)
Use of antacids containing aluminum and other aluminum containing medications or supplements during the trial
Clinically significant abnormal laboratory results at screening
Abnormal serum ferritin levels ≥200 µg/L
Abnormal serum aluminum levels >16 µg/L
eGFR < 60 and abnormal liver function tests
Allergy or sensitivity to test product ingredients
Individuals who are cognitively impaired and/or who are unable to give informed consent
Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject