An interventional study of Supplement groupx and Supplement groupx in Autoimmune Thyroiditis, sponsored by S.LAB (SOLOWAYS). Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Treatment
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.
Rationale
Secondary Goals:
27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 19 interventional studies indexed under Thyroiditis, Autoimmune.
Browse Thyroiditis, Autoimmune studies →S.LAB (SOLOWAYS) is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Supplement groupx
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).
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).
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.
Time frame: 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.
Time frame: 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Dec 2024, 7 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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S.LAB (SOLOWAYS)