Preoperative Corticosteroids in Autoimmune Thyroid Disease

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Indiana University

Status and phase

Enrolling
Phase 4

Conditions

Graves Disease
Hashimoto Disease

Treatments

Drug: Dexamethasone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05435547
10009 (Other Identifier)

Details and patient eligibility

About

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

Exclusion criteria

  • Pediatric patients < 18
  • Prior treatment with RAI
  • Prior neck surgeries
  • Known diagnosis of thyroid cancer
  • Diabetic patients on medications
  • A history of adverse reactions to corticosteroids.
  • Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

76 participants in 2 patient groups, including a placebo group

Steroids
Experimental group
Description:
Will be given pre-operative corticosteroid regimen
Treatment:
Drug: Dexamethasone
placebo
Placebo Comparator group
Description:
Will be given Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Central trial contact

Joseph Calcagno, BS; Alexandria McDow, MD

Data sourced from clinicaltrials.gov

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