Hashimoto Thyroiditis, Subacute Thyroiditis, Thyroiditis
Conditions
Keywords
Colchicine, Prednisolone, Autoimmune Thyroiditis, Inflammation, C-reactive protein, ESR, Thyroid Pain, Randomized Trial
Brief summary
Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Current management includes observation, symptomatic treatment, nonsteroidal anti-inflammatory drugs, and corticosteroids. Although corticosteroids may be effective, relapse after tapering and treatment-related adverse effects remain limitations. Colchicine is hypothesized to reduce inflammatory activity and may improve biochemical and clinical recovery. This study will evaluate the efficacy and safety of low-dose colchicine compared with corticosteroid therapy and supportive care in adults with autoimmune or subacute thyroiditis.
Detailed description
Thyroiditis represents a heterogeneous group of inflammatory thyroid disorders. Hashimoto's thyroiditis is characterized by chronic autoimmune-mediated thyroid inflammation and progressive thyroid dysfunction. Subacute thyroiditis commonly presents with painful thyroid enlargement, elevated inflammatory markers, transient thyrotoxicosis, and possible later hypothyroidism. Current treatment strategies include supportive care, nonsteroidal anti-inflammatory drugs, and corticosteroids. While corticosteroids often provide rapid symptomatic benefit, recurrence after withdrawal and steroid-related adverse effects remain clinically relevant concerns. Colchicine inhibits microtubule polymerization, leukocyte migration, and inflammasome-mediated signaling. These mechanisms may provide potential benefit in thyroid inflammatory disease. This prospective three-arm randomized controlled trial will compare colchicine, corticosteroid therapy, and supportive care regarding inflammatory improvement, thyroid function recovery, symptom control, recurrence, and tolerability. Participants will be randomized in a 1:1:1 ratio and followed for six months. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and clinical symptom improvement. Secondary outcomes include thyroid function tests, thyroid autoantibodies, ultrasound improvement, recurrence rate, need for rescue corticosteroid therapy, and adverse events. This study may help identify an effective steroid-sparing therapeutic strategy for inflammatory thyroid disorders.
Interventions
DRUGcolchicine
Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.
DRUGPrednisolone
Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.
DRUGNSAID
Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.
Sponsors
Mansoura University
Saudi German Hospital - Madinah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label trial. Participants, care providers, and investigators are aware of assigned interventions due to differences in treatment regimens.
Intervention model description
Participants will be randomized in a 1:1:1 ratio to colchicine, prednisolone, or supportive care. Study groups will be followed in parallel for 6 months to assess inflammatory, clinical, and thyroid function outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Newly diagnosed Hashimoto's thyroiditis or Subacute thyroiditis * Diagnosis confirmed clinically, biochemically, and ultrasonographically * Ability to provide written informed consent
Exclusion criteria
* Pregnancy or breastfeeding * Severe renal impairment * Severe hepatic disease * Cytopenia * Active serious infection * Known hypersensitivity to colchicine * Chronic corticosteroid use within previous 30 days * Participation in another interventional trial * Any condition affecting safety or protocol adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in C-Reactive Protein (CRP) | Baseline, Month 3, Month 6 | Reduction in serum C-reactive protein concentration compared with baseline among treatment groups. |
| Mean Change in Erythrocyte Sedimentation Rate (ESR) | Baseline, Month 3, Month 6 | Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups. |
| Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline | Baseline, Month 1, Month 3, Month 6 | Improvement in thyroid pain, neck tenderness, local discomfort, and inflammatory symptoms will be assessed using a standardized Thyroid Pain and Inflammatory Symptom Score ranging from 0 to 10, where higher scores indicate greater symptom severity and lower scores indicate clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline | Baseline, Month 3, Month 6 | Assessment of changes in serum thyroid-stimulating hormone (TSH) concentrations compared with baseline values. |
| Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline | Baseline, Month 3, Month 6 | Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values. |
| Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline | Baseline, Month 6 | Assessment of changes in serum thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) concentrations to evaluate autoimmune inflammatory activity. |
| Change in Thyroid Ultrasound Inflammatory Findings from Baseline | Baseline, Month 6 | Assessment of changes in thyroid ultrasound characteristics, including gland vascularity, parenchymal heterogeneity, gland enlargement, and inflammatory changes compared with baseline findings. |
| Recurrence Rate of Thyroiditis | Any recurrence during 6-month follow-up | Number and proportion of participants experiencing clinical or biochemical recurrence of thyroiditis after initial improvement during follow-up. |
| Need for Rescue Corticosteroid Therapy | Throughout 6-month follow-up | Number and proportion of participants requiring rescue corticosteroid treatment because of persistent symptoms, worsening inflammation, or inadequate clinical response. |
| Adverse Events / Drug Intolerance | Baseline to Month 6 | Frequency, type, and severity of adverse events or treatment intolerance including gastrointestinal symptoms, hepatic dysfunction, renal impairment, cytopenia, or steroid-related adverse effects. |
Countries
Egypt, Saudi Arabia
Contacts
CONTACTAmr A. El Sehrawy, MD, PhD, FRCPE
CONTACTAmro A. Elbaz, MD
STUDY_CHAIRAmr A. El Sehrawy, MD, PhD, FRCPE
Faculty of Medicine, Mansoura University
Outcome results
None listed