Skip to content

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01760421
Enrollment
40
Registered
2013-01-04
Start date
2011-10-31
Completion date
2013-08-31
Last updated
2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hashimoto Thyroiditis

Brief summary

Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation of thyroid gland and destroys thyroid tissue. Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis(RA) for more than one century. The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment of Hashimoto's thyroiditis.

Detailed description

Hashimoto's thyroiditis is an autoimmune thyroid disease, and when the disease progresses, thyroid function finally declined to hypothyroidism. There was no medical treatment recommended for patients with Hashimoto's thyroiditis, but currently at euthyroid state. Levothyroxine replacement therapy starts if patients become hypothyroid state. Hashimoto's thyroiditis is a T-cell mediated autoimmune thyroid disease. The major auto-antigens include thyroid peroxidase (TPO) and thyroglobulin. Anti-TPO antibodies induce antibody-dependent cell-mediated cytotoxicity (ADCC) and cause destruction of thyroid tissues. Antimalarial agents like hydroxychloroquine have several pharmacologic effects which may be involved in the treatment of rheumatic diseases, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, nicotinamide adenine dinucleotide hydrogen-cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosome membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis. This study is to investigate the treatment effect of hydroxychloroquine on autoantibodies and disease progression of Hashimoto's thyroiditis.

Interventions

DRUGHydroxychloroquine

Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Hashimoto's thyroiditis * Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit) * Never receive immunomodulators or immunosuppressants

Exclusion criteria

* Planned pregnant or already pregnant women * Renal insufficiency * Hepatic insufficiency * Anemia * Agranulocytosis * Thrombocytopenia * Glucose-6-phosphate dehydrogenase deficiency * Porphyria cutaneous tarda * Allergy to 4-aminoquinolone

Design outcomes

Primary

MeasureTime frameDescription
Anti-TPO antibody6th month after medical treatmentCheck anti-TPO antibody 6 months after medical treatment as inflammatory marker
Anti-thyroglobulin antibody6 months after medical treatmentCheck serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status

Secondary

MeasureTime frameDescription
Elasticity of thyroid gland6 months after medical treatmentMeasure the elasticity of the thyroid gland by elastography as the infiltrative degree of the thyroid
Thyroid function6 months after medical treatmentMeasure serum free T4 and thyroid-stimulating hormone level 6 months after treatment
Inflammatory cytokines6 months after treatmentMeasure plasma cytokines including interleukin-1, interleukin-6, tumor necrosis factor-alpha, 6 months after treatment

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026