Back to resultsIontophoresis With Potassium Iodide and Thyroid Function
Primary Purpose
Thyroid Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Iontophoresis with 2% potassium iodide
Sponsored by
About this trial
This is an interventional basic science trial for Thyroid Dysfunction focused on measuring Iontophoresis, potassium iodine, thyroid
Eligibility Criteria
Inclusion Criteria:
- healthy individuals with normal thyroid function
Exclusion Criteria:
- individuals with thyroid disorders,
- taking thyroid medication,
- using drugs, alcohol, cigaretttes
Sites / Locations
- Centre for Innovative Research in Medical and Natural Sciences' Medical Faculty of University of Rzeszow
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
10 iontophoresis treatments with potassium iodide
10 iontophoresis treatments with placebo
Arm Description
Outcomes
Primary Outcome Measures
the level of thyroid gland hormones (TSH, FT3, FT4)
to test thyroid hormones before and after 10 iontophoresis treatments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04013308
Brief Title
Iontophoresis With Potassium Iodide and Thyroid Function
Official Title
Iontophoresis With Potassium Iodide and the Level of Thyroid Hormones in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study: To assess the influence of iontophoresis treatment with 2% potassium iodide on the level of thyroid hormones (TSH, FT3, FT4) The study group: conducting 10 iontophoresis treatments with Potassium iodide; The control group: conducting 10 placebo treatments with iontophoresis with destilled water; Intervention: 10 iontophoresis treatments with 2% potassium iodide in healthy individuals.
Test the level of thyroid hormones before and after the 10 iontophoresis treatments; The study allows to assess the influence of iodine on the function of thuroid gland.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Dysfunction
Keywords
Iontophoresis, potassium iodine, thyroid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 iontophoresis treatments with potassium iodide
Arm Type
Experimental
Arm Title
10 iontophoresis treatments with placebo
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Iontophoresis with 2% potassium iodide
Intervention Description
10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min)
Primary Outcome Measure Information:
Title
the level of thyroid gland hormones (TSH, FT3, FT4)
Description
to test thyroid hormones before and after 10 iontophoresis treatments
Time Frame
change in the thyroid hormones level from the baseline to 14 days after the last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individuals with normal thyroid function
Exclusion Criteria:
individuals with thyroid disorders,
taking thyroid medication,
using drugs, alcohol, cigaretttes
Facility Information:
Facility Name
Centre for Innovative Research in Medical and Natural Sciences' Medical Faculty of University of Rzeszow
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-310
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34341406
Citation
Zwolinska J, Augustyn B, Baj K, Krukowska J. The effect of galvanization and potassium iodide iontophoresis of the throat and larynx on thyroid parameters: a randomized controlled trial. Sci Rep. 2021 Aug 2;11(1):15590. doi: 10.1038/s41598-021-95145-w.
Results Reference
derived
Learn more about this trial
Iontophoresis With Potassium Iodide and Thyroid Function
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