A Study of Selenomethionine and Myo-inositol(SOLOWAYS_TM) in Patients With Autoimmune Thyroiditis Carrying the DIO2 Thr92Ala Polymorphism

NCT06867913 | Completed DMC

• 1 other identifier: SW022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autoimmune Thyroiditis

Keywords

Thyroid gland; genetics; supplements; anti-TPO; T4; T3

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  16 weeks

Secondary Outcomes (6)

• Change in Serum Anti-Thyroid Peroxidase (anti-TPO) Antibody Concentration

  16 weeks

• Change in Serum Anti-Thyroglobulin (anti-Tg) Antibody Concentration

  16 weeks

• Thyroid Gland Ultrasound Measurements: Volume

  12 weeks

• Change in Patient-Reported Symptom Severity

  12 weeks

• Number of incidence of any Treatment-Related Adverse Events

  12 weeks

Study Arms (2)

Cohort A (Thr92Ala Carriers)

EXPERIMENTAL

Dietary Supplement: Supplement groupx

Cohort B (Wild-Type DIO2)

EXPERIMENTAL

Dietary Supplement: Supplement groupx

Interventions

Supplement groupx DIETARY_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).

Cohort A (Thr92Ala Carriers)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Thyroid Diseases

Condition Hierarchy (Ancestors)

Thyroiditis; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 10, 2025
• Study Start: May 15, 2024
• Primary Completion: December 26, 2024
• Study Completion: February 21, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)