Autoimmune ThyroiditisNCT06867913
A Study of Selenomethionine and Myo-inositol(SOLOWAYS_TM) in Patients With Autoimmune Thyroiditis Carrying the DIO2 Thr92Ala Polymorphism
A study testing Supplement groupx in people with Autoimmune Thyroiditis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of combined selenomethionine and myo-inositol supplementation in patients with autoimmune thyroiditis (AIT), including Hashimoto's thyroiditis, who carry the Thr92Ala (rs225014) variant in the DIO2 gene. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- Supplement groupx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2024to 21 Feb 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years with a clinical diagnosis of autoimmune thyroiditis (elevated anti- TPO and/or anti-Tg).
- TSH range consistent with subclinical hypothyroidism (e.g., TSH 4.5-10 mIU/L) or euthyroid status with AIT; patients on stable levothyroxine therapy are eligible if dose was unchanged for at least 6 weeks.
- Willingness to undergo genotyping for the DIO2 Thr92Ala variant. Confirmation of the Thr92Ala variant (homozygous or heterozygous) for Cohort A; absence of this variant for Cohort B.
- Ability to provide informed consent and comply with study procedures.
Who cannot join
- Overt hypothyroidism with TSH >10 mIU/L requiring immediate treatment adjustment.
- Significant comorbidities (e.g., uncompensated heart failure, severe renal or hepatic dysfunction, uncontrolled diabetes).
- Pregnancy or lactation (given potential changes in thyroid requirements and supplement safety considerations).
- Known hypersensitivity to selenium or inositol supplements.
- Severe psychiatric disorder interfering with protocol adherence.
- Concurrent use of high-dose selenium (>50 µg/day) or other thyroid-influencing nutraceuticals that cannot be discontinued prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Selenomethionine and Myo-inositol(SOLOWAYS_TM) in Patients With Autoimmune Thyroiditis Carrying the DIO2 Thr92Ala Polymorphism
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of combined selenomethionine and myo-inositol supplementation in patients with autoimmune thyroiditis (AIT), including Hashimoto's thyroiditis, who carry the Thr92Ala (rs225014) variant in the DIO2 gene. The study will compare changes in thyroid function tests, autoantibody titers, and clinical symptoms between two cohorts: (1) carriers (homozygous or heterozygous) of the Thr92Ala variant and (2) individuals without this variant ("wild-type"). The hypothesis is that patients with the "unfavorable" DIO2 genotype will experience greater improvements in TSH levels, the free T3/ free T4 ratio, and autoimmunity markers when receiving selenomethionine plus myo-inositol, potentially due to enhanced support of thyroid hormone conversion and reduced autoimmune activity.
Read the detailed description
Rationale
- The DIO2 gene encodes the type II iodothyronine deiodinase, which converts T4 (thyroxine) to the more active T3 (triiodothyronine) in peripheral tissues.
- The Thr92Ala (rs225014) polymorphism may reduce enzyme activity, potentially leading to lower tissue T3 levels, even in patients with normal or slightly elevated T4 and TSH.
- Selenium (as selenomethionine) supports the function of various selenoproteins, including deiodinases, and has been reported to reduce anti-thyroid antibody levels (particularly anti-TPO).
- Myo-inositol has shown promise in modulating autoimmune and metabolic processes in thyroid disorders, possibly improving tissue sensitivity to thyroid hormones and reducing autoimmune inflammation.
- A genotype-focused approach may reveal whether individuals carrying the DIO2 Thr92Ala variant derive a more substantial benefit from combined supplementation than those without the variant. 2. Study Goals
- Primary Goal: To assess changes in TSH levels and the fT3/fT4 ratio over 12 weeks of combined selenomethionine and myo-inositol supplementation.
- Secondary Goals:
- To evaluate changes in thyroid autoantibody titers (anti-TPO, anti-Tg).
- To assess thyroid ultrasound findings (vascularization, gland volume).
- To measure improvements in patient-reported symptoms and quality of life using standardized questionnaires.
- To determine the safety and tolerability of the combined intervention.
- Conditions
- Autoimmune Thyroiditis
- Being tested
- Supplement groupx
- Keywords
- Thyroid gland, genetics, supplements, anti-TPO, T4, T3
- Medical subject headings
- Thyroiditis, Autoimmune, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement groupxDietary supplement
Selenomethionine (e.g., 100 µg/day)
- Myo-inositol (e.g., 600 mg/day or higher)
- Patients on levothyroxine will maintain their current dose (if clinically indicated).
Supplement groupxDietary supplement
Selenomethionine (e.g., 100 µg/day)
- Myo-inositol (e.g., 600 mg/day or higher)
- Patients on levothyroxine will maintain their current dose (if clinically indicated).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Thr92Ala Carriers) | Experimental | Not described Receives: Dietary Supplement: Supplement groupx |
| Cohort B (Wild-Type DIO2) | Experimental | Not described Receives: Dietary Supplement: Supplement groupx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration
Change in serum TSH concentration (reported in µIU/mL) from baseline to 16 weeks. The results will be presented as the mean change in concentration.
Measured: 16 weeks
Change in Serum Free T3/Free T4 Ratio
Change in the ratio of serum free triiodothyronine (fT3) to free thyroxine (fT4) from baseline to 16 weeks. The outcome will be reported as the mean ratio change.
Measured: 16 weeks
Secondary outcomes (6)
Change in Serum Anti-Thyroid Peroxidase (anti-TPO) Antibody Concentration
Change in the concentration of serum anti-thyroid peroxidase (anti-TPO) antibodies (measured in IU/mL) from baseline to 16 weeks. The outcome will be reported as the mean change in antibody concentration.
Measured: 16 weeks
Change in Serum Anti-Thyroglobulin (anti-Tg) Antibody Concentration
Change in the concentration of serum anti-thyroglobulin (anti-Tg) antibodies (measured in IU/mL) from baseline to 16 weeks. The outcome will be reported as the mean change in antibody concentration.
Measured: 16 weeks
Thyroid Gland Ultrasound Measurements: Volume
Ultrasound assessment of the thyroid gland will include measurement of thyroid volume (in mL) and qualitative assessment of thyroid echogenicity. Thyroid volume will be calculated using standardized ultrasound techniques, and echogenicity will be rated using a predetermined grading system.
Measured: 12 weeks
Change in Patient-Reported Symptom Severity
Patient-reported symptom severity will be assessed using the Patient Health Questionnaire-15 [PHQ-15]). , if the PHQ-15, scores range from 0 to 30, with higher scores indicating worse symptom severity. The outcome will be reported as the mean change in symptom severity score from baseline to 12 weeks.
Measured: 12 weeks
Number of incidence of any Treatment-Related Adverse Events
The incidence of treatment-related adverse events will be recorded and graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Data will be reported as the number and percentage of participants experiencing one or more adverse events.
Measured: 12 weeks
Change in Patient-Reported Quality of Life
Quality of life will be assessed using a validated instrument such as the World Health Organization Quality of Life-BREF (WHOQOL-BREF). For instance, scores for each domain range from 0 to 100, with higher scores indicating a better quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 May 2024
- Primary completion26 Dec 2024
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune ThyroiditisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867913
- Sponsor's protocol ID
- SW022
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Selenomethionine and Myo-inositol(SOLOWAYS_TM) in Patients With Autoimmune Thyroiditis Carrying the DIO2 Thr92Ala Polymorphism
- ClinicalTrials.gov ID
- NCT06867913
- Acronym / sponsor ID
- SW022
- Conditions
- Autoimmune Thyroiditis
- Keywords
- Thyroid gland, genetics, supplements, anti-TPO, T4, T3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 15 May 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 10 Mar 2025 (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.
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of combined selenomethionine and myo-inositol supplementation in patients with autoimmune thyroiditis (AIT), including Hashimoto's thyroiditis, who carry the Thr92Ala (rs225014) variant in the DIO2 gene. The study will compare changes in thyroid function tests, autoantibody titers, and clinical symptoms between two cohorts: (1) carriers (homozygous or heterozygous) of the Thr92Ala variant and (2) individuals without this variant ("wild-type"). The hypothesis is that patients with the "unfavorable" DIO2 genotype will experience greater improvements in TSH levels, the free T3/ free T4 ratio, and autoimmunity markers when receiving selenomethionine plus myo-inositol, potentially due to enhanced support of thyroid hormone conversion and reduced autoimmune activity.
Detailed description
Rationale
- The DIO2 gene encodes the type II iodothyronine deiodinase, which converts T4 (thyroxine) to the more active T3 (triiodothyronine) in peripheral tissues.
- The Thr92Ala (rs225014) polymorphism may reduce enzyme activity, potentially leading to lower tissue T3 levels, even in patients with normal or slightly elevated T4 and TSH.
- Selenium (as selenomethionine) supports the function of various selenoproteins, including deiodinases, and has been reported to reduce anti-thyroid antibody levels (particularly anti-TPO).
- Myo-inositol has shown promise in modulating autoimmune and metabolic processes in thyroid disorders, possibly improving tissue sensitivity to thyroid hormones and reducing autoimmune inflammation.
- A genotype-focused approach may reveal whether individuals carrying the DIO2 Thr92Ala variant derive a more substantial benefit from combined supplementation than those without the variant. 2. Study Goals
- Primary Goal: To assess changes in TSH levels and the fT3/fT4 ratio over 12 weeks of combined selenomethionine and myo-inositol supplementation.
- Secondary Goals:
- To evaluate changes in thyroid autoantibody titers (anti-TPO, anti-Tg).
- To assess thyroid ultrasound findings (vascularization, gland volume).
- To measure improvements in patient-reported symptoms and quality of life using standardized questionnaires.
- To determine the safety and tolerability of the combined intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Thr92Ala Carriers) | Experimental | Dietary Supplement: Supplement groupx |
| Cohort B (Wild-Type DIO2) | Experimental | Dietary Supplement: Supplement groupx |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years with a clinical diagnosis of autoimmune thyroiditis (elevated anti- TPO and/or anti-Tg).
- TSH range consistent with subclinical hypothyroidism (e.g., TSH 4.5-10 mIU/L) or euthyroid status with AIT; patients on stable levothyroxine therapy are eligible if dose was unchanged for at least 6 weeks.
- Willingness to undergo genotyping for the DIO2 Thr92Ala variant. Confirmation of the Thr92Ala variant (homozygous or heterozygous) for Cohort A; absence of this variant for Cohort B.
- Ability to provide informed consent and comply with study procedures.
Key exclusion criteria (6 listed)
- Overt hypothyroidism with TSH >10 mIU/L requiring immediate treatment adjustment.
- Significant comorbidities (e.g., uncompensated heart failure, severe renal or hepatic dysfunction, uncontrolled diabetes).
- Pregnancy or lactation (given potential changes in thyroid requirements and supplement safety considerations).
- Known hypersensitivity to selenium or inositol supplements.
- Severe psychiatric disorder interfering with protocol adherence.
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 |
|---|---|---|
| Supplement groupxSelenomethionine (e.g., 100 µg/day) * Myo-inositol (e.g., 600 mg/day or higher) * Patients on levothyroxine will maintain their current dose (if clinically indicated). | Dietary supplement | Cohort A (Thr92Ala Carriers) |
| Supplement groupxSelenomethionine (e.g., 100 µg/day) * Myo-inositol (e.g., 600 mg/day or higher) * Patients on levothyroxine will maintain their current dose (if clinically indicated). | Dietary supplement | Cohort B (Wild-Type DIO2) |
Primary outcome
Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration
Time frame: 16 weeks
Change in serum TSH concentration (reported in µIU/mL) from baseline to 16 weeks. The results will be presented as the mean change in concentration.
Change in Serum Free T3/Free T4 Ratio
Time frame: 16 weeks
Change in the ratio of serum free triiodothyronine (fT3) to free thyroxine (fT4) from baseline to 16 weeks. The outcome will be reported as the mean ratio change.
6 secondary outcomes
Change in Serum Anti-Thyroid Peroxidase (anti-TPO) Antibody Concentration
Time frame: 16 weeks
Change in Serum Anti-Thyroglobulin (anti-Tg) Antibody Concentration
Time frame: 16 weeks
Thyroid Gland Ultrasound Measurements: Volume
Time frame: 12 weeks
Change in Patient-Reported Symptom Severity
Time frame: 12 weeks
Number of incidence of any Treatment-Related Adverse Events
Time frame: 12 weeks
Change in Patient-Reported Quality of Life
Time frame: 12 weeks
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 11 Apr 2025.
- 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 Supplement groupx in people with Autoimmune Thyroiditis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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 4 inclusion and 6 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 11 Apr 2025. 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 Russia. 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?
Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.