Phase
Condition
Female Hormonal Deficiencies/abnormalities
Thyroid Disease
Hormone Deficiencies
Treatment
Gluten Free Diet in Hashimoto's Hypothyroidism
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Diagnosis of Hashimoto's thyroiditis
Self-perception of reduced quality of life since diagnosis as determined by a ThyPRO score greater than or equal to 35 (higher score suggests lower quality-of-life) based on prior studies reporting of average score in individuals with symptomatic hypothyroidism.
Hypothyroidism requiring use of thyroid hormone replacement >6 months prior initiation of study
Thyroid hormone levels (TSH, Free T4 and Free T3 as available) within the normal reference range within 3 months of the study initiation
Anti-TPO AB greater than or equal to 500 IU/mL and/or Anti-Tg AB greater than or equal to 50 IU/mL at any point in medical history
Exclusion Criteria
Prior surgical intervention on thyroid
Prior Celiac Disease diagnosis or symptoms which are highly suggestive of undiagnosed Celiac Disease (i.e. chronic diarrhea, blood in stool, unintentional weight loss, family history, etc). In the case of the latter, patients will be directed to speak with their physician to consider screening before being considered for enrollment into the study.
Pregnancy
Use of gluten-free diet within prior 6 months
Active malignancy undergoing treatment
Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study
Study Design
Study Description
Connect with a study center
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
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