Status:
COMPLETED
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Central Arkansas Veterans Healthcare System
Conditions:
Subclinical Hypothyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negati...
Detailed Description
This is a pilot, randomized, double-blind, placebo-controlled trial. Methodology: The investigators will conduct a double-blind, placebo-controlled clinical trial where eligible veterans diagnosed w...
Eligibility Criteria
Inclusion
- Veterans
- diagnosis of SCH
Exclusion
- thyroid-stimulating hormone (TSH) \> 10 milli-international units per liter (mlU/L) (at any point)
- Levothyroxine (LT4) dose more than 75 mcg daily
- use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium
- history of thyroidectomy or radioactive iodine therapy
- LT4 suppressive therapy for thyroid cancer, goiter, or inflammation
- pregnancy or plans for pregnancy in the next 6 months
- an unstable medical condition that would jeopardize safety or interfere with study participation
- severe hypothyroidism-related symptoms
- strong family history of hypothyroidism
- severe dyslipidemia
- hospitalization for major illness within the previous 4 weeks
- acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12 months
- grade IV New York Heart Association heart failure
- receiving services from hospice
- lack of decision-making capacity
- terminal medical condition for which life expectancy would be less than 6 months
- not willing to stop LT4
- self-reported non-adherence to LT4 therapy
- abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04288115
Start Date
March 24 2021
End Date
December 31 2022
Last Update
November 18 2023
Active Locations (1)
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1
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, United States, 72114-1706