Phase 4
N=50
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Subclinical Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT04288115 ↗Enrolled (actual)
50
Serious AEs
9.1%
Results posted
Nov 2023
Primary outcome: Primary: Participants' Willingness to Enter the Trial — 52 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levothyroxine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2022
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 |
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.
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). 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.