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

June 4, 2014 updated by: KGK Science Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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
Experimental: SierraSil Joint Formula 14
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
667 mg SierraSil® hydrothermal mineral complex
Other Names:
  • SierraSil® hydrothermal mineral complex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
WOMAC osteoarthritis index Pain Subscale as a measure of osteoarthritis pain
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WOMAC osteoarthritis index Stiffness subscale as a measure of osteoarthritis stiffness
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks
WOMAC osteoarthritis index Physical Function subscale as a measure of physical function
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks
SF-36 questionnaire score as a measure of Quality of Life
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks
Inflammatory markers
Time Frame: 4 weeks
hsCRP, TNF-alpha, IL-6 assessed during each 4 week treatment period
4 weeks
Amount of Rescue Medication Used
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks
Vital Signs
Time Frame: 4 weeks
Blood pressure, heart rate, weight and BMI were assessed during each 4 week treatment period
4 weeks
Safety Blood Parameters
Time Frame: 4 weeks
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
4 weeks
Number of participants with Adverse Events as measure of safety
Time Frame: 4 weeks
Assessed during each 4 week treatment period
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KGK Science Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SierraSil Health Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11SOHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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