NCT05435547

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
8mo left

Started Jun 2023

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

January 25, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

January 25, 2022

Last Update Submit

April 28, 2025

Conditions

Graves DiseaseHashimoto Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day of Surgery

Secondary Outcomes (14)

  • Change in blood flow / vascularity

    Pre-operative visit and Day of Surgery

  • Surgical complication of transient hypocalcemia

    Two weeks post-operative and six weeks post-operative

  • Surgical complication of permanent hypocalcemia

    through study completion, or 6 months

  • Surgical complication of transient hypoparathyroidism

    Two weeks post-operative and six weeks post-operative

  • Surgical complication of permanent hypoparathyroidism

    through study completion, or 6 months

  • +9 more secondary outcomes

Study Arms (2)

Steroids

EXPERIMENTAL

Will be given pre-operative corticosteroid regimen

Drug: Dexamethasone

placebo

PLACEBO COMPARATOR

Will be given Placebo

Drug: Placebo

Interventions

DexamethasoneDRUG

Will take Dexamethasone pre-operatively

Steroids
PlaceboDRUG

Will take Placebo pre-operatively

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • â–  Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IU Health North Hospital

Indianapolis, Indiana, 46032, United States

RECRUITING

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Graves DiseaseHashimoto Disease

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesThyroiditis, AutoimmuneThyroiditis

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Alexandria McDow, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandria McDow, MD

CONTACT

317-944-4377amcdow@iu.edu

Hannah Allison, MA

CONTACT

hralliso@iu.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 25, 2022

First Posted

June 28, 2022

Study Start

June 16, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)