Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-27 @ 1:22 PM
Study NCT ID:
NCT01125592
Status:
COMPLETED
Last Update Posted:
2011-11-15
First Post:
2010-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-14', 'studyFirstSubmitDate': '2010-05-14', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2011-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in heavy metal content in the water after a 30 minute IonCleanse footbath', 'timeFrame': '4 sessions, May 26 to June 17 2010', 'description': 'The footbath water will be assessed after each footbath session for each participant via a drinking water assessment performed by an accredited lab.\n\nScreening 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['assess the ability of the IonCleanse machine to remove heavy metals through the feet'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22174728', 'type': 'RESULT', 'citation': 'Kennedy DA, Cooley K, Einarson TR, Seely D. Objective assessment of an ionic footbath (IonCleanse): testing its ability to remove potentially toxic elements from the body. J Environ Public Health. 2012;2012:258968. doi: 10.1155/2012/258968. Epub 2011 Nov 29.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Adults\n\nExclusion Criteria:\n\n* A wearer of a pacemaker or any other battery operated or electrical implant\n* Pregnant or nursing women\n* On heartbeat regulating medication\n* On blood thinners (anticoagulants)\n* On any drug known to have chelating properties\n* Have had an organ transplant or a metal joint implant\n* On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.'}, 'identificationModule': {'nctId': 'NCT01125592', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'The Canadian College of Naturopathic Medicine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IonFootbath'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Footbath', 'description': 'Participants in this arm of the study will receive 4 30 minutes ionic footbath sessions, one each week for 4 weeks.', 'interventionNames': ['Device: IonCLeanse Footbath']}], 'interventions': [{'name': 'IonCLeanse Footbath', 'type': 'DEVICE', 'otherNames': ['IonCleanse SOLO machine manufactured by A Major Difference'], 'description': 'Application of an ionic footbath for 30 minutes per week for 4 weeks', 'armGroupLabels': ['Footbath']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2K 1E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian College of Naturopathic Medicine', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Canadian College of Naturopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research & Clinical epidemiology', 'investigatorFullName': 'Dugald Seely', 'investigatorAffiliation': 'The Canadian College of Naturopathic Medicine'}}}}