Recruiting

Corticosteroids

Sponsor:

Indiana University

Code:

NCT05435547

Conditions

Graves Disease

Hashimoto Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Placebo

Study Details

Brief summary:

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.

Conditions

Graves Disease

Hashimoto Disease

Study ID

NCT05435547

Start date

Jun 16, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Steroids

Will be given pre-operative corticosteroid regimen

placebo comparator: placebo

Will be given Placebo

Interventions

Dexamethasone

Will take Dexamethasone pre-operatively

Placebo

Will take Placebo pre-operatively

Primary outcome measure

  • Thyroid difficulty Scale score [ Time Frame: Day of Surgery ]

Central Contacts and Locations

Central contacts

Alexandria McDow, MD

317-944-4377amcdow@iu.edu

Hannah Allison, MA

hralliso@iu.edu

Locations

IU Health North Hospital

Recruiting

Indianapolis, Indiana, United States, 46032

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

IU Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Aug 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-05.