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Osteoarthritis of the KneePhase 211SOHSNCT02156440

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

A Phase 2 study testing SierraSil Joint Formula 14 in people with Osteoarthritis of the Knee, run by KGK Science Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
SierraSil Joint Formula 14
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteCanada
Study dates
Sep 2011to Apr 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • OR
  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Double Blind, Placebo Controlled Cross Over Study to Explore the Efficacy of SierraSil® Joint Formula 14™ in Adults With Osteoarthritis of the Knee

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.

Being tested
SierraSil Joint Formula 14, Placebo
Keywords
Ostearthritis, Knee, SierraSil
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SierraSil Joint Formula 14Dietary supplement

    Also called SierraSil® hydrothermal mineral complex

    667 mg SierraSil® hydrothermal mineral complex

  • PlaceboDietary supplement

Study groups in NCT02156440
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo capsules: one capsule taken 3 times per day with water. Subjects are to drink 6 to 8 glasses of water daily.
Receives: Dietary Supplement: Placebo
SierraSil Joint Formula 14ExperimentalSierraSil Joint Formula 14 capsules: one capsule taken 3 times per day with water. Subjects are to drink 6 to 8 glasses of water daily.
Receives: Dietary Supplement: SierraSil Joint Formula 14

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC osteoarthritis index Pain Subscale as a measure of osteoarthritis pain

    Assessed during each 4 week treatment period

    Measured: 4 weeks

Secondary outcomes (8)

  1. WOMAC osteoarthritis index Stiffness subscale as a measure of osteoarthritis stiffness

    Assessed during each 4 week treatment period

    Measured: 4 weeks

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

    Assessed during each 4 week treatment period

    Measured: 4 weeks

  3. SF-36 questionnaire score as a measure of Quality of Life

    Assessed during each 4 week treatment period

    Measured: 4 weeks

  4. Inflammatory markers

    hsCRP, TNF-alpha, IL-6 assessed during each 4 week treatment period

    Measured: 4 weeks

  5. Amount of Rescue Medication Used

    Assessed during each 4 week treatment period

    Measured: 4 weeks

  6. Vital Signs

    Blood pressure, heart rate, weight and BMI were assessed during each 4 week treatment period

    Measured: 4 weeks

  7. Safety Blood Parameters

    CBC, electrolytes, fasting glucose, creatinine, eGFR AST, ALT, GGT, bilirubin, creatine kinase, aluminum, ferritin, TIBC and iron saturation were assessed during each of the 4 week treatment periods

    Measured: 4 weeks

  8. Number of participants with Adverse Events as measure of safety

    Assessed during each 4 week treatment period

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2014 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156440
Sponsor's protocol ID
11SOHS
Acronym
11SOHS
Status last verified
Jun 2014
First submitted
2 Jun 2014
Last updated
5 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SierraSil Joint Formula 14 in people with Osteoarthritis of the Knee, run by KGK Science Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC osteoarthritis index Pain Subscale as a measure of osteoarthritis pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.

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