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NCT Number: NCT07571681

Colchicine for Autoimmune and Subacute Thyroiditis

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.

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Key information

Conditions

Hashimoto Thyroiditis Autoimmune Diseases Endocrine System Diseases Hashimoto Disease Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Subacute Thyroiditis Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune Thyroiditis, Subacute

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.

Prednisolone

Drug

Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.

NSAID

Drug

Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.

Primary outcomes

  1. Mean Change in C-Reactive Protein (CRP)

    Time frame: Baseline, Month 3, Month 6

    Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.

  2. Mean Change in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline, Month 3, Month 6

    Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.

  3. Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline

    Time frame: 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 outcomes

  1. Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline

    Time frame: Baseline, Month 3, Month 6

    Assessment of changes in serum thyroid-stimulating hormone (TSH) concentrations compared with baseline values.

  2. Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline

    Time frame: Baseline, Month 3, Month 6

    Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values.

  3. Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline

    Time frame: Baseline, Month 6

    Assessment of changes in serum thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) concentrations to evaluate autoimmune inflammatory activity.

  4. Change in Thyroid Ultrasound Inflammatory Findings from Baseline

    Time frame: Baseline, Month 6

    Assessment of changes in thyroid ultrasound characteristics, including gland vascularity, parenchymal heterogeneity, gland enlargement, and inflammatory changes compared with baseline findings.

  5. Recurrence Rate of Thyroiditis

    Time frame: 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.

  6. Need for Rescue Corticosteroid Therapy

    Time frame: Throughout 6-month follow-up

    Number and proportion of participants requiring rescue corticosteroid treatment because of persistent symptoms, worsening inflammation, or inadequate clinical response.

  7. Adverse Events / Drug Intolerance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amr A. El Sehrawy, MD, PhD, FRCPE

CONTACT

[email protected]

+966503845019

Amro A. Elbaz, MD

CONTACT

[email protected]

+201000191910

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Saudi German Hospital - Madinah

Registry information

Official study title

Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial

Acronym: COLTHYR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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