Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis: A Case-Control Study (NCT07453290) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Dysregulation of the Soluble α-Klotho-FGF23 Axis in Hashimoto's Thyroiditis: A Case-Control Study
150 participantsStarted 2026-03-02
Plain-language summary
Hashimoto's thyroiditis (HT) is the most common autoimmune thyroid disease and is increasingly recognized as a condition associated with chronic low-grade systemic inflammation beyond thyroid hormone dysfunction. The soluble α-Klotho-fibroblast growth factor 23 (FGF23) axis plays a central role in mineral metabolism, inflammation, and aging-related pathways; however, its involvement in HT has not been adequately characterized.
This prospective case-control study aims to compare serum soluble α-Klotho and FGF23 levels between adults with Hashimoto's thyroiditis and age- and sex-matched healthy controls, and to investigate their associations with thyroid function parameters, inflammatory markers, and autoimmune burden. In addition, the FGF23/sKlotho ratio will be evaluated as an integrated marker of functional imbalance within the Klotho-FGF23 axis.
The study seeks to determine whether Hashimoto's thyroiditis is associated with systemic dysregulation of the Klotho-FGF23 pathway independent of renal function and mineral metabolism.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged 18-65 years
Ability to provide written informed consent
Hashimoto group: Diagnosis of Hashimoto's thyroiditis based on positive anti-thyroid peroxidase (anti-TPO) and/or anti-thyroglobulin (anti-TG) antibodies with compatible clinical/ultrasound findings (as available)
Control group: No history of thyroid disease or autoimmune disease; normal thyroid function tests (TSH and free T4 within reference range)
Exclusion Criteria:
Pregnancy or breastfeeding
Known chronic kidney disease (eGFR \< 60 mL/min/1.73 m²)
Active infection or acute inflammatory condition within the past 4 weeks
Known malignancy under active treatment
Chronic inflammatory/autoimmune disease other than Hashimoto's thyroiditis (e.g., rheumatoid arthritis, SLE, IBD)
Use of systemic glucocorticoids or immunosuppressive therapy within the past 3 months
Known parathyroid disease or disorders of calcium/phosphate metabolism
Current use of medications strongly affecting mineral metabolism (e.g., phosphate binders, active vitamin D analogs)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Serum Soluble α-Klotho Levels Between Hashimoto's Thyroiditis and Healthy Controls
Timeframe: Baseline
Trial details
NCT IDNCT07453290
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital