NCT04288115

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism: a Pilot Randomized, Double-blinded, Placebo-controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Subclinical Hypothyroidism

Interventions

Type	Name	Description
DRUG	Levothyroxine	Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
OTHER	Placebo	Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-10-07
• Completion: 2022-12-31
• First posted: 2020-02-28
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study