Graves DiseasePhase 4NCT05435547
Preoperative Corticosteroids in Autoimmune Thyroid Disease
A Phase 4 study testing Dexamethasone in people with Graves Disease and Hashimoto Disease, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease, Hashimoto Disease
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2023to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Allison, MA contact
United States3 sites, 3 recruiting
- Recruiting
IU Health North Hospital
Indianapolis, Indiana, 46032
Robin Gardiner
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Robin Gardiner
- Recruiting
IU Health University Hospital
Indianapolis, Indiana, 46202
Robin Gardiner
About this study
Official title: Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
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
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Graves Disease, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Will take Dexamethasone pre-operatively
PlaceboDrug
Will take Placebo pre-operatively
| Study group | Role | What they receive |
|---|---|---|
| Steroids | Experimental | Will be given pre-operative corticosteroid regimen Receives: Drug: Dexamethasone |
| placebo | Placebo comparator | Will be given Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid difficulty Scale score
This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.
Measured: Day of Surgery
Secondary outcomes (14)
Change in blood flow / vascularity
The surgeon will use ultrasound to assess the vascularity of the surgical area. Scoring is dependent on thyroid gland size, whether there is substernal extension, and the level of vascularity. The minimum score (2) indicates normal vascularity and normal gland size with no substernal extension. The maximum score (11) indicates extensive vascularity and large gland size with substernal extension.
Measured: Pre-operative visit and Day of Surgery
Surgical complication of transient hypocalcemia
Number of subjects with transient hypocalcemia (calcium <8.5)
Measured: Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypocalcemia
Number of subjects with permanent hypocalcemia (calcium <8.5)
Measured: through study completion, or 6 months
Surgical complication of transient hypoparathyroidism
Number of subjects with Post-op PTH <10
Measured: Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypoparathyroidism
Number of subjects with Post-op PTH <10
Measured: through study completion, or 6 months
Surgical complication of recurrent laryngeal nerve palsy
Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy
Measured: Two weeks post-operative and six-weeks post-operative, if clinically indicated
Change in SF-20 at 6 weeks
score ranges from 0 to 100, higher scores indicate better functioning or quality of life
Measured: Six weeks post-operative
Change in SF-20 at 6 months
score ranges from 0 to 100, higher scores indicate better functioning or quality of life
Measured: through study completion, an average of 6 months
Tg
Tg, 1.3-31.8 ng/mL;
Measured: through study completion, an average of 6 months
TgAB
TgAB, 0-4.0 IU/mL;
Measured: through study completion, an average of 6 months
TPO
TPO AB 0-9.0 IU/mL;
Measured: through study completion, an average of 6 months
TSI
TSI 0-0.54 IU/L;
Measured: through study completion, an average of 6 months
TRAb
TRAb 0-1.75 IU/L
Measured: through study completion, an average of 6 months
ThyPRO
0 points (best outcome) - 340 points (worst outcome)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start16 Jun 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandria D. McDow, Indiana University
- Investigators
- Alexandria McDow, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435547
- Sponsor's protocol ID
- 10009
- Status last verified
- May 2026
- First submitted
- 25 Jan 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
- ClinicalTrials.gov ID
- NCT05435547
- Acronym / sponsor ID
- 10009
- Conditions
- Graves Disease, Hashimoto Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroids | Experimental | Drug: DexamethasoneWill be given pre-operative corticosteroid regimen |
| placebo | Placebo comparator | Drug: PlaceboWill be given Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneWill take Dexamethasone pre-operatively | Drug | Steroids |
| PlaceboWill take Placebo pre-operatively | Drug | placebo |
Primary outcome
Thyroid difficulty Scale score
Time frame: Day of Surgery
This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.
14 secondary outcomes
Change in blood flow / vascularity
Time frame: Pre-operative visit and Day of Surgery
Surgical complication of transient hypocalcemia
Time frame: Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypocalcemia
Time frame: through study completion, or 6 months
Surgical complication of transient hypoparathyroidism
Time frame: Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypoparathyroidism
Time frame: through study completion, or 6 months
Surgical complication of recurrent laryngeal nerve palsy
Time frame: Two weeks post-operative and six-weeks post-operative, if clinically indicated
Change in SF-20 at 6 weeks
Time frame: Six weeks post-operative
Change in SF-20 at 6 months
Time frame: through study completion, an average of 6 months
Tg
Time frame: through study completion, an average of 6 months
TgAB
Time frame: through study completion, an average of 6 months
TPO
Time frame: through study completion, an average of 6 months
TSI
Time frame: through study completion, an average of 6 months
TRAb
Time frame: through study completion, an average of 6 months
ThyPRO
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Allison, MA contact
Alexandria McDow, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Graves Disease and Hashimoto Disease, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandria McDow, MD (317-944-4377, amcdow@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid difficulty Scale score (time frame: Day of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.