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Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125592
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : November 15, 2011
Sponsor:
Information provided by (Responsible Party):
Dugald Seely, The Canadian College of Naturopathic Medicine

Study Description
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Brief Summary:
Makers of ionic foot baths claim that their machines can eliminate heavy metals from the body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the machine under controlled conditions. The machine will first be tested without feet under normal operating conditions and again after operation under normal conditions with foot immersion.

Condition or disease Intervention/treatment Phase
Healthy Device: IonCLeanse Footbath Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Footbath
Participants in this arm of the study will receive 4 30 minutes ionic footbath sessions, one each week for 4 weeks.
 Device: IonCLeanse Footbath
Application of an ionic footbath for 30 minutes per week for 4 weeks
Other Name: IonCleanse SOLO machine manufactured by A Major Difference


Outcome Measures
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Primary Outcome Measures :
  1. Change in heavy metal content in the water after a 30 minute IonCleanse footbath [ Time Frame: 4 sessions, May 26 to June 17 2010 ]

    The footbath water will be assessed after each footbath session for each participant via a drinking water assessment performed by an accredited lab.

    Screening for heavy metals will be done via a 24 urine collection and Urine Toxic Metals assessment four times during the study - baseline, during 2nd and 4th footbath sessions and then at the 3 month mark post baseline.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adults

Exclusion Criteria:

  • A wearer of a pacemaker or any other battery operated or electrical implant
  • Pregnant or nursing women
  • On heartbeat regulating medication
  • On blood thinners (anticoagulants)
  • On any drug known to have chelating properties
  • Have had an organ transplant or a metal joint implant
  • On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125592


Locations
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Canada, Ontario
Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
More Information
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Publications of Results:

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Responsible Party: Dugald Seely, Director of Research & Clinical epidemiology, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01125592    
Other Study ID Numbers: IonFootbath
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011
Keywords provided by Dugald Seely, The Canadian College of Naturopathic Medicine:
assess the ability of the IonCleanse machine to remove heavy metals through the feet