Adjuvant Therapeutic Effect of Vitamin D on Hashimoto's Thyroiditis

NCT05871957 | Unknown

• 1 other identifier: YXLL-KY-2021(041)
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the relationship between vitamin D and Hashimoto's thyroiditis and to explore whether vitamin D can play an adjuvant role in the treatment of Hashimoto's thyroiditis. Epidemiological surveys show that vitamin D deficiency rates are as high as 50%-90% in HT patients. Dietary supplementation with vitamin D has been evaluated as a way to protect the thyroid gland from autoimmune damage, but the results of randomized clinical trials are unclear.

Conditions

Hashimoto Thyroiditis

Outcome Measures

Primary Outcomes (1)

• TPOAB in IU/ml

  Thyroid peroxisomes, a thyroid autoantibodies

  Data for each participant will be collected within 3 days

Secondary Outcomes (4)

• TGAB in IU/ml

  Data for each participant will be collected within 3 days

• FT3 in pmol/L

  Data for each participant will be collected within 3 days

• FT4 in pmol/L

  Data for each participant will be collected within 3 days

• TSH in uIU/ml

  Data for each participant will be collected within 3 days

Study Arms (2)

Serum vitamin D deficiency in Hashimoto's thyroiditis during hypothyroidism

Serum vitamin D levels are lower than normal

Drug: Vitamin D Drops

Patients with normal serum vitamin D during hypothyroidism in Hashimoto's thyroiditis

Serum vitamin D levels are within normal limits

Interventions

Vitamin D Drops DRUG

Supplement 2000IU of vitamin D, no matter the brand or manufacturer for 1 month.

Also known as: Vitamin D

Serum vitamin D deficiency in Hashimoto's thyroiditis during hypothyroidism

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hashimoto's thyroiditis patients with hypothyroidism.

You may qualify if:

• Meeting the diagnostic criteria of Hashimoto's thyroiditis in Western medicine (according to the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases - Thyroiditis and the Guidelines for the Diagnosis and Treatment of hypothyroidism in adults).
• Signing informed consent.

You may not qualify if:

• Patients with thyroid cancer;
• Other thyroid related diseases, such as Graves' disease;
• History of thyroid surgery or radioiodine therapy;
• Life history of iodine deficiency area with goiter;
• Immunosuppressive agents or immunomodulatory agents (mannan peptide, ubenamex, cyclophosphamide, incense) should be used within 1 month Polysaccharide, interferon, glucocorticoid, etc.); Other proprietary Chinese medicine (Bailing capsule, Prunella capsule, etc.)
• Patients taking chronic medications that may interfere with thyroid hormone or vitamin D metabolism;
• pregnancy plan during pregnancy or within six months;
• Severe liver and renal dysfunction;
• Serious systemic diseases, such as heart failure, stroke, and malignant tumors;
• With other autoimmune diseases: type 1 diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, Vitiligo, autoimmune adrenal dysfunction;
• Those who are supplementing other trace elements;
• People allergic to vitamin D;
• Patients with hypercalcemia or other related diseases or mental disorders are unwilling to cooperate.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yuying Cui

  Qianfoshan Hospital

  STUDY CHAIR

Central Study Contacts

Lin Liao, Doctor

CONTACT

18354117713; liaolin@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: May 23, 2023
• Study Start: June 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05