Hashimoto's Thyroiditis, HT
Conditions
Interventions
Intervention Group:Oral vitamin D3 supplementation
Placebo Group:Placebo
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 50 years. 2. Meeting the diagnostic criteria for early Hashimoto's thyroiditis (HT), as defined by: Serum TPOAb > 34 IU/mL and/or TGAb > 115 IU/mL; Heterogeneous echogenicity or reticular pattern changes on thyroid ultrasound; Normal clinical presentation, TSH, and thyroid function. 3. No clinical intervention with immunomodulators (e.g., thymopentin, interferons, human immunoglobulin for injection, glucocorticoids, cyclophosphamide, azathioprine), vitamins, or other trace elements within the past 3 months. 4. Capable of complying with the study protocol (e.g., completing medication intake, examinations, and follow-ups as required by the protocol). 5. No contraindications or allergies to the supplements included in the study.
Exclusion criteria
Exclusion criteria: 1. Coexistence of Graves ophthalmopathy, dermopathy, granulocytopenia, thyroid nodules, hypothyroidism, thyroid and/or other organ malignancies. 2. Diagnosis of other autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, etc. 3. Severe hepatic or renal dysfunction (with alanine aminotransferase or serum creatinine levels exceeding 1.5 times the upper limit of normal as defined by the hospital); severe cardiovascular or cerebrovascular diseases (e.g., heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, or having undergone interventional procedures); stage 3 hypertension (systolic blood pressure not controlled below 160 mmHg despite the use of three antihypertensive agents). 4. Infectious diseases including HBsAg-positive hepatitis B, active pulmonary tuberculosis, AIDS, etc. 5. Any psychiatric disorder; epilepsy or current use of antiepileptic drugs; current use of antidepressant medications. 6. Lack of cognitive capacity. 7. Women who are pregnant, breastfeeding, or planning to become pregnant within the next 6 months. 8. Chronic medical conditions (e.g., diabetes mellitus, chronic obstructive pulmonary disease, arthritis, chronic liver disease, etc.). 9. History of organic brain diseases (including cerebral trauma, intracranial tumors, cerebral hemorrhage, cerebral infarction, or other cerebrovascular diseases). 10. Use of medications affecting bone metabolism within the past 6 months (e.g., bisphosphonates, glucocorticoids, estrogen, estrogen receptor agonists, immunosuppressants, chemotherapeutic agents, etc.). 11. History of fracture or presence of bone diseases. 12. Diagnosis of hyperparathyroidism. 13. Alcohol abuse (defined as daily alcohol intake >40 grams for women [approximately equivalent to 250 ml of rice wine, 400 ml of beer, or 80 ml of distilled spirits] or >80 grams for men). 14. Participation in another clinical trial within the past 3 months or current enrollment in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thyroid profile:TPOAb?TGAb?TSH?FT3?FT4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG);Cytokine testing:IL?TNF;Liver and renal function tests:AST?ALT?TG?TC?Cr?Ca;Bone metabolism markers:25(OH)D?PTH; | — |
Countries
China
Contacts
Public ContactGaohong Zhu
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed