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

NCT02156440 | Completed Phase 2

• 1 other identifier: 11SOHS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Keywords

Ostearthritis; Knee; SierraSil

Outcome Measures

Primary Outcomes (1)

• WOMAC osteoarthritis index Pain Subscale as a measure of osteoarthritis pain

  Assessed during each 4 week treatment period

  4 weeks

Secondary Outcomes (8)

• WOMAC osteoarthritis index Stiffness subscale as a measure of osteoarthritis stiffness

  4 weeks

• WOMAC osteoarthritis index Physical Function subscale as a measure of physical function

  4 weeks

• SF-36 questionnaire score as a measure of Quality of Life

  4 weeks

• Inflammatory markers

  4 weeks

• Amount of Rescue Medication Used

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsules: one capsule taken 3 times per day with water. Subjects are to drink 6 to 8 glasses of water daily.

Dietary Supplement: Placebo

SierraSil Joint Formula 14

EXPERIMENTAL

SierraSil Joint Formula 14 capsules: one capsule taken 3 times per day with water. Subjects are to drink 6 to 8 glasses of water daily.

Dietary Supplement: SierraSil Joint Formula 14

Interventions

SierraSil Joint Formula 14 DIETARY_SUPPLEMENT

667 mg SierraSil® hydrothermal mineral complex

Also known as: SierraSil® hydrothermal mineral complex

SierraSil Joint Formula 14

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• SierraSil Health Inc: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dale Wilson, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

CA (1)