The Impact of Change of Thyroid Antibodies on Hormone Level and Disease Burden in Patients With Hashimoto's Thyroiditis
NCT ID: NCT07048821
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-05-05
2023-09-15
Brief Summary
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Detailed Description
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Primary outcomes: Anti-TPO antibodies, Anti-Thyroglobulin antibodies, TSH, T3, T4 Secondary outcomes: BMI, Lipid profile, Symptoms of hypothyroidism
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients with hashimoto thyroiditis
The investigators advised patients to follow a modified Mediterranean diet plan with a reduction in goitrogenic foods for 12 weeks.
Dietary modification
3-month dietary plan
Interventions
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Dietary modification
3-month dietary plan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive anti-thyroid antibodies (anti-TPO/anti-TG).
Exclusion Criteria
* Age below 20 years and above 50 years
* presence of any other medical disorder
20 Years
50 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Sherihan AboElyazed Mohamed Khalil
OTHER
Responsible Party
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Sherihan AboElyazed Mohamed Khalil
Lecturer of Endocrinology and Internal Medicine Faculty of Medicine, Ain Shams University Cairo, Egypt
Principal Investigators
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Manal Abushady, MD
Role: STUDY_DIRECTOR
faculty of medicine, Ain Shams University
Locations
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Ain Shams University hospital
Cairo, , Egypt
Countries
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References
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Groenewegen KL, Mooij CF, van Trotsenburg ASP. Persisting symptoms in patients with Hashimoto's disease despite normal thyroid hormone levels: Does thyroid autoimmunity play a role? A systematic review. J Transl Autoimmun. 2021 Apr 15;4:100101. doi: 10.1016/j.jtauto.2021.100101. eCollection 2021.
Watt T, Hegedus L, Bjorner JB, Groenvold M, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U. Is Thyroid Autoimmunity per se a Determinant of Quality of Life in Patients with Autoimmune Hypothyroidism? Eur Thyroid J. 2012 Oct;1(3):186-92. doi: 10.1159/000342623. Epub 2012 Sep 29.
Watt T, Hegedus L, Groenvold M, Bjorner JB, Rasmussen AK, Bonnema SJ, Feldt-Rasmussen U. Validity and reliability of the novel thyroid-specific quality of life questionnaire, ThyPRO. Eur J Endocrinol. 2010 Jan;162(1):161-7. doi: 10.1530/EJE-09-0521. Epub 2009 Oct 1.
Danailova Y, Velikova T, Nikolaev G, Mitova Z, Shinkov A, Gagov H, Konakchieva R. Nutritional Management of Thyroiditis of Hashimoto. Int J Mol Sci. 2022 May 5;23(9):5144. doi: 10.3390/ijms23095144.
Bellastella G, Scappaticcio L, Caiazzo F, Tomasuolo M, Carotenuto R, Caputo M, Arena S, Caruso P, Maiorino MI, Esposito K. Mediterranean Diet and Thyroid: An Interesting Alliance. Nutrients. 2022 Oct 4;14(19):4130. doi: 10.3390/nu14194130.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MS 232/2023
Identifier Type: -
Identifier Source: org_study_id
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