Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism: a Pilot Randomized, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Participants' Willingness to Enter the Trial
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of SCH
排除标准
- •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)
研究组 & 干预措施
Levothyroxine group ("sham discontinuation")
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
干预措施: Levothyroxine (Drug)
Placebo group ("real discontinuation")
Stop the current dose of levothyroxine and take study placebo
干预措施: Placebo (Other)
结局指标
主要结局
Participants' Willingness to Enter the Trial
时间窗: The time from first consent signed to last consent signed. March 2021 to April 2022.
Percent of eligible participants approached who consented to participate during the recruitment phase.
Recruitment Rate
时间窗: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.
The number of enrolled (consented) participants divided by the length of the recruitment period.
Completion Rate
时间窗: 6 months
Percentage of randomized participants who completed the trial.
次要结局
- Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score(Baseline, 6 weeks and 6 months)
- Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score(Baseline, 6 weeks and 6 months)
- Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6(6 weeks and 6 months)
- Lipid Levels(6 months)