Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

VA Office of Research and Development52 enrolled

Overview

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 negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.

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 with SCH and on LT4 will be 1:1 randomized to either continue LT4 or change to placebo. The primary outcome is intervention feasibility (willingness to enter the trial, recruitment rate, and completion rate). Secondary outcomes are: 1) changes in QoL measures (Hypothyroid Symptom \[HSS\] and Tiredness scale scores of the Thyroid-Specific Patient-Related Outcome Measure \[ThyPRO\], EuroQoL 5-Dimension Self-Report Questionnaire) measured at baseline, 6-8 weeks and 6 months and 2) changes in lipids assessed at baseline and 6 months, and 3) incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, fractures, acute myocardial infarction, stroke, acute coronary syndrome, heart failure, mortality).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Subclinical Hypothyroidism

Interventions

LevothyroxineDRUG

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

PlaceboOTHER

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Veterans * diagnosis of SCH Exclusion Criteria: * 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)

Locations (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Participants' Willingness to Enter the Trial

Percent of eligible participants approached who consented to participate during the recruitment phase.

Time frame: The time from first consent signed to last consent signed. March 2021 to April 2022.

Recruitment Rate

The number of enrolled (consented) participants divided by the length of the recruitment period.

Time frame: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.

Completion Rate

Percentage of randomized participants who completed the trial.

Time frame: 6 months

Secondary Outcomes

Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score

The Hypothyroid Symptoms score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more symptoms.

Time frame: Baseline, 6 weeks and 6 months

Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score

The Tiredness score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more tiredness.

Time frame: Baseline, 6 weeks and 6 months

Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6

The EuroQoL \[EQ\] Group 5-Dimension Self-Report Questionnaire (EQ-5D) scores include the EQ-5D descriptive index, on a scale from -0.59 to 1.00. Higher scores indicate better quality of life. The EQ-5D scores include the score on the EQ visual-analogue scale (EQ-5D VAS), on a scale from 0 to 100. Higher scores indicate better quality of life.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.