Clinical trial Recruiting at 3 sites Phase 4 Interventional Ages 18 and up

Using corticosteroids before surgery for autoimmune thyroid disease

Official title: Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease

Run by Indiana University · NCT05435547 · Data updated 2026-11-12

This study tests if taking a short course of corticosteroids before thyroid surgery can help people with Graves' disease or Hashimoto's disease have a smoother operation.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment76 (estimated)
SponsorIndiana University
Academic / other
Locations3 sites (Indianapolis, Indiana and 2 other locations)
StatusRecruiting
StartedJune 16, 2023
Main results expectedDecember 30, 2026
Study endsJune 30, 2027
Registry record updatedAugust 5, 2026
Trial IDNCT05435547 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with Graves' disease or Hashimoto's disease who are preparing for total thyroidectomy and have positive thyroid autoantibodies.

Probably not a fit

Patients under 18, those with a history of thyroid cancer, or individuals on immunosuppressive therapies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to randomize patients with Graves' disease or Hashimoto's disease who are scheduled for total thyroidectomy. It will evaluate whether a short course of corticosteroids, specifically dexamethasone, can reduce inflammation of the thyroid gland and facilitate a smoother surgical procedure. Participants will be compared against a placebo group to assess the effectiveness of the intervention. The study focuses on patients with positive thyroid autoantibodies undergoing surgery for their condition.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients with autoimmune thyroid disease.

How similar studies have gone: While the specific approach of using corticosteroids preoperatively in this context is not widely tested, similar studies have shown promise in reducing inflammation in other surgical settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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.

Where it's running

  • IU Health North Hospital
    Indianapolis, Indiana, United States
    Recruiting
  • IU Health Methodist Hospital
    Indianapolis, Indiana, United States
    Recruiting
  • IU Health University Hospital
    Indianapolis, Indiana, United States
    Recruiting

Study contacts

  • Principal investigator: Alexandria McDow, MD — Indiana University
  • Study coordinator: Alexandria McDow, MD
  • Email: amcdow@iu.edu
  • Phone: 317-944-4377

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.