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Corticosteroid

Dexamethasone for Autoimmune Thyroid Disease

Phase 4
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Study Summary

This trial will study if corticosteroids can reduce inflammation before thyroid surgery to make the operation easier. #medicine

Who is the study for?
This trial is for adults with Graves' disease or Hashimoto's thyroiditis planning to have their thyroid removed. They must have certain autoantibodies present and not be on immunosuppressants, diabetic medication, or have a history of neck surgeries, steroid therapy, adverse reactions to corticosteroids, or any drug interactions.Check my eligibility
What is being tested?
The study is testing if taking a short course of Dexamethasone (a corticosteroid) before surgery can reduce inflammation in the thyroid gland compared to a placebo. Patients are randomly assigned to either receive Dexamethasone or an inactive substance.See study design
What are the potential side effects?
Dexamethasone may cause increased blood sugar levels, mood swings, high blood pressure, weight gain, insomnia and increase the risk of infections. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Graves' or Hashimoto's disease and am having my thyroid removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thyroid difficulty Scale score
Secondary outcome measures
Calcium
FT4
Number of participants with the following surgical complications
+11 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SteroidsExperimental Treatment1 Intervention
Will be given pre-operative corticosteroid regimen
Group II: placeboPlacebo Group1 Intervention
Will be given Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Graves' Disease is commonly treated with thionamides (e.g., methimazole), radioactive iodine, and sometimes surgery. Thionamides inhibit thyroid hormone synthesis, while radioactive iodine destroys overactive thyroid tissue. Corticosteroids, such as prednisone, are used for their anti-inflammatory properties; they inhibit peripheral conversion of T4 to T3 and reduce thyroid hormone secretion. This is particularly important for patients experiencing severe hyperthyroidism or thyroid storm, as corticosteroids can rapidly reduce inflammation and hormone levels, providing symptomatic relief and preventing complications.
Focus on Autoimmune Myocarditis in Graves' Disease: A Case-Based Review.Case Report: Novel Dietary Supplementation Associated With Kidney Recovery and Reduction in Proteinuria in a Dialysis Dependent Patient Secondary to Steroid Resistant Minimal Change Disease.Acute management of autoimmune toxicity in cancer patients on immunotherapy: Common toxicities and the approach for the emergency physician.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,207 Total Patients Enrolled
~46 spots leftby Dec 2025
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