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NCT07060118 · ClinicalTrials.gov registry record · NA
Gluten Free Diet in Hashimoto's Hypothyroidism
A NA study of Hypothyroidism and Hashimoto Disease, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07060118 is a NA study of Hypothyroidism and Hashimoto Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 823-participant average among 9 other Hypothyroidism trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07060118, a NA study of Hypothyroidism and Hashimoto Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Hashimoto's thyroiditis is an autoimmune condition that reduces functioning of the thyroid gland and can lead to a substantial decline in quality of life for patients, with impacted patients often describing unremitting brain fog, fatigue/malaise and weight gain leading to difficulty functioning in their jobs and homes. It is the most common cause of hypothyroidism in the U.S. and affects up to 10% of the global population. The typical treatment for Hashimoto's is thyroid hormone replacement with medications such as levothyroxine. However, despite adequate treatment as defined by thyroid hormone levels within the reference range, up to 10% of patients will experience persisting symptoms which can dramatically impair quality of life. While various theories have been postulated for the residual symptoms, several studies indicate that they are related to the thyroid autoimmunity, specifically the autoantibodies that are made by the immune system in Hashimoto's thyroiditis in response to the thyroid (ie thyroid peroxidase \[TPO\], thyroglobulin \[Tg\] antibody \[AB\]) and the associated inflammation with the immune response. Removal of thyroid (ie total thyroidectomy) reduces levels of these thyroid antibodies and results in significant improvement in quality-of-life. However, thyroidectomy is an invasive procedure with potential for morbidity such as damage to the recurrent laryngeal (nerve that controls the vocal cords and thus speech), bleeding and infection, so there is interest in other more conservative modalities for lowering the inflammation and autoimmune burden in Hashimoto's thyroiditis. In an effort to identify a less invasive approach for reducing the levels of thyroid antibodies and inflammation, attention has moved to the intersection of Hashimoto's thyroiditis and the gut. Hashimoto's has a strong association with autoimmune disorders impacting the gastrointestinal tract, in particular celiac disease and non-celiac gluten sensitivity (NCGS). NCGS is a c
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Gluten Free Diet in Hashimoto's Hypothyroidism
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07060118
The ClinicalTrials.gov registry entry for NCT07060118 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 823-participant average among 9 other Hypothyroidism trials with a reported enrollment target (94% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypothyroidism appearing as the primary indexed condition, and to 1 intervention - of which Gluten Free Diet in Hashimoto's Hypothyroidism is the first listed.
NCT07060118 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT07060118 about?
NCT07060118 is a clinical study titled "Gluten Free Diet in Hashimoto's Hypothyroidism". Hashimoto's thyroiditis is an autoimmune condition that reduces functioning of the thyroid gland and can lead to a substantial decline in quality of life for patients, with impacted patients often describing unremitting brain fog, fatigue/malaise and weight gain leading to difficulty functioning in ...
What is the current status of trial NCT07060118?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-07-15. Estimated completion is 2026-06-30.
What conditions does trial NCT07060118 study?
This clinical trial studies the following conditions: Hypothyroidism, Hashimoto Disease.
What interventions are being tested in trial NCT07060118?
The interventions under investigation include: Gluten Free Diet in Hashimoto's Hypothyroidism (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07060118?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07060118 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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