Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dugald Seely, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT01125592
First received: May 14, 2010
Last updated: November 14, 2011
Last verified: November 2011
  Purpose
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 Intervention Phase
Healthy
Device: IonCLeanse Footbath
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • Change in heavy metal content in the water after a 30 minute IonCleanse footbath [ Time Frame: 4 sessions, May 26 to June 17 2010 ] [ Designated as safety issue: No ]

    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.



Enrollment: 6
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125592

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

Publications:
Responsible Party: Dugald Seely, Director of Research & Clinical epidemiology, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01125592     History of Changes
Other Study ID Numbers: IonFootbath 
Study First Received: May 14, 2010
Last Updated: November 14, 2011
Health Authority: Canada: local Ethics Review Committee

Keywords provided by The Canadian College of Naturopathic Medicine:
assess the ability of the IonCleanse machine to remove heavy metals through the feet

ClinicalTrials.gov processed this record on December 08, 2016