NCT04013308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

July 3, 2019

Last Update Submit

August 14, 2019

Conditions

Keywords

Iontophoresispotassium iodinethyroid

Outcome Measures

Primary Outcomes (1)

  • the level of thyroid gland hormones (TSH, FT3, FT4)

    to test thyroid hormones before and after 10 iontophoresis treatments

    change in the thyroid hormones level from the baseline to 14 days after the last treatment

Study Arms (2)

10 iontophoresis treatments with potassium iodide

EXPERIMENTAL
Procedure: Iontophoresis with 2% potassium iodide

10 iontophoresis treatments with placebo

NO INTERVENTION

Interventions

10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min)

10 iontophoresis treatments with potassium iodide

Eligibility Criteria

Age19 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals with normal thyroid function

You may not qualify if:

  • individuals with thyroid disorders,
  • taking thyroid medication,
  • using drugs, alcohol, cigaretttes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Innovative Research in Medical and Natural Sciences' Medical Faculty of University of Rzeszow

Rzeszów, Podkarpackie Voivodeship, 35-310, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Thyroid Diseases

Interventions

IontophoresisPotassium Iodide

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesIodidesIodine CompoundsInorganic ChemicalsPotassium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Physical Factors

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 9, 2019

Study Start

May 27, 2019

Primary Completion

July 30, 2019

Study Completion

July 31, 2019

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations