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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hashimoto's thyroiditis (HT) is an autoimmune disease affecting the thyroid gland and is one of the most common causes of hypothyroidism. Eating habits may affect the risk of several inflammatory and immune diseases, such as HT. The current knowledge of the diet in HT is insufficient. The Mediterranean diet (MD) is an anti-inflammatory diet characterized by frequent consumption of olive oil, unrefined cereals, fresh or dried fruit and vegetables, moderate amounts of fish, dairy, and meat, and many condiments and spices. It is rich in nutrients and bioactives, which have the potential to offer anti-inflammatory aspects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators aimed to assess the impact of the Mediterranean diet on patients with Hashimoto thyroiditis using the following outcomes:

Primary outcomes: Anti-TPO antibodies, Anti-Thyroglobulin antibodies, TSH, T3, T4 Secondary outcomes: BMI, Lipid profile, Symptoms of hypothyroidism

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hashimoto Thyroiditis Mediterranean Diet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with hashimoto thyroiditis

The investigators advised patients to follow a modified Mediterranean diet plan with a reduction in goitrogenic foods for 12 weeks.

Group Type EXPERIMENTAL

Dietary modification

Intervention Type DIETARY_SUPPLEMENT

3-month dietary plan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary modification

3-month dietary plan

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mediterranean diet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with symptoms of hypothyroidism (hypothyroid/euthyroid)
* Positive anti-thyroid antibodies (anti-TPO/anti-TG).

Exclusion Criteria

* Pregnant or lactating females
* Age below 20 years and above 50 years
* presence of any other medical disorder
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role collaborator

Sherihan AboElyazed Mohamed Khalil

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sherihan AboElyazed Mohamed Khalil

Lecturer of Endocrinology and Internal Medicine Faculty of Medicine, Ain Shams University Cairo, Egypt

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manal Abushady, MD

Role: STUDY_DIRECTOR

faculty of medicine, Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University hospital

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34027377 (View on PubMed)

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.

Reference Type RESULT
PMID: 24783018 (View on PubMed)

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.

Reference Type RESULT
PMID: 19797502 (View on PubMed)

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.

Reference Type RESULT
PMID: 35563541 (View on PubMed)

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.

Reference Type RESULT
PMID: 36235782 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MS 232/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.