Dexamethasone for Autoimmune Thyroid Disease

Recruiting at 2 trial locations

Overseen By Hannah Allison, MA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Indiana University

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Diabetes, Thyroid cancer, others

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether giving patients anti-inflammatory medication (corticosteroids) before thyroid surgery can reduce gland inflammation and make the surgery easier. The focus is on patients with autoimmune thyroid disease, where the immune system attacks the thyroid, causing inflammation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients on immunosuppressive drugs or those with a recent history of steroid therapy. If you are on these medications, you may not be eligible to participate.

What evidence supports the effectiveness of the drug dexamethasone for autoimmune thyroid disease?

Research shows that dexamethasone can increase thyroid hormone levels in patients with severe Hashimoto's thyroiditis by reducing autoimmune processes that inhibit hormone production. Additionally, dexamethasone is effective in treating Graves' ophthalmopathy, a condition related to thyroid disease, suggesting its potential benefit in autoimmune thyroid conditions. ^{1 2 3 4 5}

How does the drug dexamethasone differ from other treatments for autoimmune thyroid disease?

Dexamethasone is unique because it can reduce the autoimmune processes that inhibit thyroid hormone synthesis, potentially increasing hormone levels in patients with severe Hashimoto's thyroiditis. Unlike some other treatments, it can also be a cost-effective alternative for managing Graves' ophthalmopathy without the risk of liver failure associated with other therapies. ^{1 3 4 6 7}

Research Team

Alexandria McDow, MD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I have Graves' or Hashimoto's disease and am having my thyroid removed.

Exclusion Criteria

I have been diagnosed with thyroid cancer.

I have had surgery on my neck before.

I am taking medication that doesn't mix well with corticosteroids.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive a short course of corticosteroids or placebo before surgery to reduce thyroid inflammation

1-2 weeks

Surgery

Participants undergo surgery for autoimmune, inflammatory thyroid disease

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of surgical complications and thyroid function

6 months

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Steroids Experimental Treatment 1 Intervention

Will be given pre-operative corticosteroid regimen

Group II: placebo Placebo Group 1 Intervention

Will be given Placebo

Dexamethasone is already approved in Canada, Japan for the following indications:

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

In a study involving 22 patients with Hashimoto's thyroiditis, administering 2 mg of dexamethasone for 2-4 weeks led to a decrease in plasma T4, T3, and TSH levels in euthyroid patients, indicating a reduction in thyroid activity and size.

In contrast, in hypothyroid patients with high TSH levels, dexamethasone increased plasma T3 and T4 levels, suggesting that it may stimulate hormone synthesis by reducing autoimmune processes that inhibit thyroid function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An increase of plasma triiodothyronine and thyroxine after administration of dexamethasone to hypothyroid patients with Hashimoto's thyroiditis. Yamada, T., Ikejiri, K., Kotani, M., et al.[2013]

L-thyroxine (T4) treatment in euthyroid pediatric patients with type 1 diabetes and autoimmune thyroiditis stabilizes autoimmune inflammation in the thyroid gland, as evidenced by decreased levels of anti-thyroid peroxidase antibodies over 24 months.

The study involved 101 children receiving L-T4 and 160 under observation, showing that T4 treatment led to significant changes in thyroid hormone levels, including a decrease in TSH and an increase in free T4, suggesting it may help prevent progression to hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-thyroxine stabilizes autoimmune inflammatory process in euthyroid nongoitrous children with Hashimoto's thyroiditis and type 1 diabetes mellitus. Korzeniowska, K., Jarosz-Chobot, P., Szypowska, A., et al.[2022]

A 71-year-old woman with autoimmune hyperthyroidism and ACTH deficiency showed significant improvement in her symptoms and thyroid condition after receiving hydrocortisone replacement therapy, indicating the efficacy of glucocorticoids in managing her autoimmune thyroid disease.

The case suggests that low cortisol levels may contribute to hyperimmunity and autoimmune thyroid disease, as the patient's hyperthyroidism resolved rapidly with glucocorticoid treatment, leading to decreased thyroid antibody levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoimmune hyperthyroidism due to secondary adrenal insufficiency: resolution with glucocorticoids. Skamagas, M., Geer, EB.[2022]

A study involving 21 patients with Graves's ophthalmopathy found that pulse dexamethasone therapy is a cost-effective alternative to pulse methylprednisolone therapy, reducing treatment costs by at least 1/8th.

Dexamethasone therapy not only proved to be equally effective but also showed a better reduction in exophthalmos and did not carry the risk of fulminant hepatic failure associated with high-dose methylprednisolone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse dexamethasone therapy versus pulse methylprednisolone therapy for treatment of Graves's ophthalmopathy. Philip, R., Saran, S., Gutch, M., et al.[2022]

Dexamethasone administration led to a significant increase in serum reverse T3 (rT3) levels and a decrease in serum triiodothyronine (T3) levels in both hypothyroid and hyperthyroid patients, indicating a shift in thyroid hormone metabolism.

The study suggests that dexamethasone alters the conversion of thyroxine (T4) to T3 and rT3, potentially reducing T3 production while enhancing rT3 production, and also appears to lower circulating thyroid hormones in hyperthyroid patients by decreasing thyroid secretion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opposite effects of dexamethasone on serum concentrations of 3,3',5'-triiodothyronine (reverse T3) and 3,3'5-triiodothyronine (T3). Chopra, IJ., Williams, DE., Orgiazzi, J., et al.[2013]

In a study involving 4 hyperthyroid patients with Graves' disease, a daily dose of 30 mg prednisolone rapidly normalized serum T4 and T3 levels within 2 weeks, demonstrating its efficacy in managing hyperthyroidism.

Prednisolone was effective as a preoperative preparation for subtotal thyroidectomy, especially for patients who experienced adverse effects from traditional antithyroid drugs, suggesting it can be a valuable alternative treatment in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid improvement of thyroid function by using glucocorticoid indicated for the preoperative preparation of subtotal thyroidectomy in Graves' disease. Ozawa, Y., Daida, H., Shimizu, T., et al.[2019]

Autoimmune thyroid disease includes conditions like Hashimoto's thyroiditis and Graves' disease, which can lead to serious complications such as hypothyroidism and extrathyroidal manifestations like ophthalmopathy.

In the U.S., most adults with Graves' disease receive radioiodine therapy for treatment, while those with Hashimoto's thyroiditis often require lifelong levothyroxine therapy if they develop hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying autoimmune thyroid disease. Which disorders require treatment? Fatourechi, V.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

An increase of plasma triiodothyronine and thyroxine after administration of dexamethasone to hypothyroid patients with Hashimoto's thyroiditis. [2013]

2. Turkey pubmed.ncbi.nlm.nih.gov

L-thyroxine stabilizes autoimmune inflammatory process in euthyroid nongoitrous children with Hashimoto's thyroiditis and type 1 diabetes mellitus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Autoimmune hyperthyroidism due to secondary adrenal insufficiency: resolution with glucocorticoids. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Pulse dexamethasone therapy versus pulse methylprednisolone therapy for treatment of Graves's ophthalmopathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Opposite effects of dexamethasone on serum concentrations of 3,3',5'-triiodothyronine (reverse T3) and 3,3'5-triiodothyronine (T3). [2013]

6. Japan pubmed.ncbi.nlm.nih.gov

Rapid improvement of thyroid function by using glucocorticoid indicated for the preoperative preparation of subtotal thyroidectomy in Graves' disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Demystifying autoimmune thyroid disease. Which disorders require treatment? [2016]