Phase 4
Completed N=50
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Source: ClinicalTrials.gov NCT04288115 ↗Enrolled (actual)
50
Serious AEs
9.1%
Results posted
Nov 2023
Primary outcomePrimary: Participants' Willingness to Enter the Trial — 52 Participants
◆ Published Evidence
Emerging
5citations · ~5 / year
Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial.
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 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.
Linked Publications
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Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants' Willingness to Enter the Trial |
52 | — |
| PRIMARY Recruitment Rate |
4 | — |
| PRIMARY Completion Rate |
44 | — |
| SECONDARY Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score |
21.1; 27.1; 22.0; 25.3; 22.9; 28.3 | 0.0913 |
| SECONDARY Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score |
31.1; 33.2; 33.0; 31.1; 32.8; 27.6 | 0.0036 sig |
| SECONDARY Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6 |
0.759; 0.786; 0.742; 0.750; 78.0; 77.2 | 0.4684 |
| SECONDARY Lipid Levels |
145.3; 177.4; 76.5; 100.2; 42.7; 51.5 | 0.1695 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04288115) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.