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

NCT ID: NCT06867913

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-02-21

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A (Thr92Ala Carriers)

Group Type: EXPERIMENTAL

Supplement groupx

Intervention Type: 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 B (Wild-Type DIO2)

Group Type: EXPERIMENTAL

Supplement groupx

Intervention Type: 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).

Interventions

Supplement groupx

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).

Intervention Type: DIETARY_SUPPLEMENT

Supplement groupx

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for New Medical Technologies, Novosibirsk, Russia

OTHER

Sponsor Role: collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for New Medical Technologies

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

SW022

Identifier Type: -

Identifier Source: org_study_id