Thyroid DysfunctionNCT04013308
Iontophoresis With Potassium Iodide and Thyroid Function
A study testing Iontophoresis with 2% potassium iodide in people with Thyroid Dysfunction, run by University of Rzeszow at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Dysfunction
- What is being tested?
- Iontophoresis with 2% potassium iodide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 27 May 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals with normal thyroid function
Who cannot join
- individuals with thyroid disorders,
- taking thyroid medication,
- using drugs, alcohol, cigaretttes
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre for Innovative Research in Medical and Natural Sciences' Medical Faculty of University of Rzeszow
Rzeszów, Podkarpackie Voivodeship, 35-310
About this study
Official title: Iontophoresis With Potassium Iodide and the Level of Thyroid Hormones in Healthy Subjects
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.
- Conditions
- Thyroid Dysfunction
- Being tested
- Iontophoresis with 2% potassium iodide
- Keywords
- Iontophoresis, potassium iodine, thyroid
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis with 2% potassium iodideProcedure or surgery
10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min)
| Study group | Role | What they receive |
|---|---|---|
| 10 iontophoresis treatments with potassium iodide | Experimental | Not described Receives: Procedure: Iontophoresis with 2% potassium iodide |
| 10 iontophoresis treatments with placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of thyroid gland hormones (TSH, FT3, FT4)
to test thyroid hormones before and after 10 iontophoresis treatments
Measured: change in the thyroid hormones level from the baseline to 14 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start27 May 2019
- Primary completion30 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Zwolińska, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013308
- Sponsor's protocol ID
- URzeszow scientific circle
- Status last verified
- Aug 2019
- First submitted
- 3 Jul 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34341406
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iontophoresis With Potassium Iodide and the Level of Thyroid Hormones in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04013308
- Acronym / sponsor ID
- URzeszow scientific circle
- Conditions
- Thyroid Dysfunction
- Keywords
- Iontophoresis, potassium iodine, thyroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 iontophoresis treatments with potassium iodide | Experimental | Procedure: Iontophoresis with 2% potassium iodide |
| 10 iontophoresis treatments with placebo | No intervention | – |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals with normal thyroid function
Key exclusion criteria (3 listed)
- individuals with thyroid disorders,
- taking thyroid medication,
- using drugs, alcohol, cigaretttes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis with 2% potassium iodide10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min) | Procedure or surgery | 10 iontophoresis treatments with potassium iodide |
Primary outcome
the level of thyroid gland hormones (TSH, FT3, FT4)
Time frame: change in the thyroid hormones level from the baseline to 14 days after the last treatment
to test thyroid hormones before and after 10 iontophoresis treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 34341406Zwolinska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis with 2% potassium iodide in people with Thyroid Dysfunction, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of thyroid gland hormones (TSH, FT3, FT4) (time frame: change in the thyroid hormones level from the baseline to 14 days after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019; AzTrials last refreshed its copy on 26 Oct 2026.