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Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism

2026年8月21日 更新者：Spyridoula Maraka

Discontinuation of Low Dose Levothyroxine Therapy for Older Adults With Subclinical Hypothyroidism: a Randomized, Double-blinded, Placebo-controlled Study

The goal of this clinical trial is to learn whether low-dose levothyroxine can be safely discontinued in adults aged 65 years or older who are taking levothyroxine for subclinical hypothyroidism. The study will also evaluate the cost-effectiveness of discontinuing levothyroxine.

The main questions it aims to answer are:

  • Does discontinuing levothyroxine result in no clinically meaningful worsening of thyroid-related symptoms compared with continuing levothyroxine?
  • What are the effects of discontinuing levothyroxine on quality of life, tiredness, cognition, thyroid hormone levels, lipid levels, weight, and adverse events?
  • Is discontinuing levothyroxine cost-effective compared with continuing treatment?

Researchers will compare participants who discontinue levothyroxine and receive placebo with participants who continue their current dose of levothyroxine to determine the effects of levothyroxine discontinuation.

Participants will:

  • Complete a 2-week run-in period during which they continue their usual levothyroxine and record their medication use.
  • Eligible participants will be randomly assigned to either continue their current dose of levothyroxine or receive a matching placebo for 6 months. Participants, their clinicians, and study investigators will not know which treatment they are receiving during the study.
  • Complete study assessments at baseline, approximately 2 months, and 6 months. Assessments will include blood tests, measurements such as body weight, questionnaires about thyroid-related symptoms and quality of life, and assessments of cognition and other health outcomes.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

138

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72205
        • Central Arkansas Veterans Healthcare System
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Spyridoula Maraka, M.D., M.S.
    • Florida
      • Gainesville、Florida、アメリカ、32610
        • University of Florida Clinical Research Center
        • コンタクト：
        • 主任研究者：
          • Naykky Singh Ospina, M.D., M.S.
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic
        • コンタクト：
          • Juan Pablo Brito Campana, M.B.B.S.
          • 電話番号：(507) 266-0500
          • メール：brito.juan@mayo.edu
        • 主任研究者：
          • Juan Pablo Brito Campana, M.B.B.S.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Age ≥65 years.
  2. Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range.
  3. Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months.
  4. Receiving levothyroxine at a dose ≤50 mcg/day, or ≤25 mcg/day for participants weighing <50 kg.
  5. Receiving outpatient care at the participating study site for at least 12 months.

Subclinical hypothyroidism is defined as a TSH level above the normal reference range but <10 mIU/L, with a normal fT4 level, prior to initiation of levothyroxine therapy.

Exclusion Criteria:

  1. TSH >10 mIU/L at any time documented in the institutional electronic health record.
  2. Levothyroxine therapy initiated less than 6 months before enrollment.
  3. Abnormal thyroid function at the time of enrollment.
  4. Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium.
  5. History of thyroid cancer or goiter with compressive symptoms.
  6. History of partial or total thyroidectomy or radioactive iodine therapy.
  7. New York Heart Association (NYHA) Class IV heart failure.
  8. Hospitalization for a major illness or elective surgery within the previous 4 weeks, including acute coronary syndrome, acute myocarditis, pancarditis, or stroke.
  9. Unstable medical condition that, in the investigator's judgment, would jeopardize participant safety or interfere with study participation.
  10. Terminal illness with a life expectancy of less than 6 months.
  11. Lack of decision-making capacity.
  12. Severe dyslipidemia, defined as LDL cholesterol >190 mg/dL.
  13. Untreated depression.
  14. Uncontrolled psychiatric disorder.
  15. Uncontrolled chronic fatigue syndrome.
  16. Uncontrolled pain.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Levothyroxine Continuation
Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
薬：Levothyroxine Pill
Participants assigned to the levothyroxine continuation arm will continue levothyroxine at their pre-study dose (≤50 mcg/day) for 6 months. Levothyroxine will be administered orally once daily as over-encapsulated study medication matched in appearance to placebo to maintain blinding.
実験的：Levothyroxine Discontinuation
Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.
薬：Placebo
Participants assigned to the levothyroxine discontinuation arm will discontinue levothyroxine and receive matching placebo orally once daily for 6 months. Placebo will be over-encapsulated and matched in appearance to the active study medication to maintain blinding.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months
時間枠：6 months
Thyroid-related symptoms will be assessed using the 4-item Thyroid-specific Patient Reported Outcome (ThyPRO) Hypothyroid Symptoms Scale. Scores are transformed to a 0-100 scale, with higher scores indicating more severe hypothyroid symptoms. The mean 6-month score will be compared between the levothyroxine discontinuation (placebo) group and the levothyroxine continuation group. The prespecified noninferiority margin is 9 points.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
時間枠：Baseline, 2 months, 6 months
Mean score on the 4-item ThyPRO Hypothyroid Symptoms Score. Scores range from 0 to 100, with higher scores indicating more severe hypothyroid symptoms. Longitudinal changes will be evaluated between treatment groups.
Baseline, 2 months, 6 months
Mean ThyPRO Tiredness Scale Score
時間枠：Baseline, 2 month, and 6 months
Tiredness will be assessed using the 7-item ThyPRO Tiredness Scale. Scores range from 0 to 100, with higher scores indicating greater tiredness. Mean scores and longitudinal changes will be compared between treatment groups.
Baseline, 2 month, and 6 months
Mean Brief Fatigue Inventory Score
時間枠：Baseline, 2 months, and 6 months
Fatigue will be assessed during the 9-item Brief Fatigue Inventory (BFI). Items are scored from 0 to 10 and the mean item score will be calculated, with higher scores indicating greater fatigue severity or interference. Mean scores and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Patient-Generated Index Visual Analogue Scale Score
時間枠：Baseline, 2 months, and 6 months
Participant-identified symptoms considered important and related to subclinical hypothyroidism will be assessed using the Patient-Generated Index (PGI) visual analogue scale. Scores range from 0-100, with higher scores indicating less severe symptoms. Mean scores and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean ThyPRO-39 Quality-of-Life Score
時間枠：Baseline and 6 months
Thyroid-specific quality of life will be assessed using the 39-item ThyPRO-39 questionnaire. Scores range from 0 to 100, with higher scores indicating worse thyroid-related quality of life. Mean scores will be compared between treatment groups.
Baseline and 6 months
Mean EQ-5D Descriptive Index Score
時間枠：Baseline, 2 months, and 6 months
General health-related quality of life will be assessed using the EQ-5D descriptive index. Scores range from -0.59 to 1.00, with higher scores indicating better health-related quality of life. Mean scores and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean EQ Visual Analogue Scale Score
時間枠：Baseline, 2 months, and 6 months
Self-rated health will be assessed using the EQ visual analogue scale (EQ VAS). Scores range from 0 to 100, with higher scores indicating better self-rated health. Mean scores and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Number of Participants Preferring Study Treatment Versus Pre-Study Treatment
時間枠：2 months and 6 months
Participants will report whether they prefer the treatment they are currently receiving during the study or their pre-study levothyroxine treatment. The number and percentage of participants reporting each preference will be summarized by treatment group.
2 months and 6 months
Mean Modified Telephone Interview for Cognitive Status Score
時間枠：Baseline and 6 months
Cognitive function will be assessed using the Modified Telephone Interview for Cognitive Status (TICS-M), a 13-item cognitive assessment evaluating orientation, concentration, memory, naming, calculation, comprehension, and reasoning. Total scores range from 0 to 39, with higher scores indicating better cognitive performance. Mean scores will be compared between treatment groups.
Baseline and 6 months
Mean Body Weight
時間枠：Baseline, 2 months, and 6 months
Body weight will be measured in kilograms. Mean body weight and change in body weight will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Thyroid-Stimulating Hormone Level
時間枠：Baseline, 2 months, and 6 months
Serum thyroid-stimulating hormone (TSH) will be measured in mIU/L to assess thyroid function. Mean TSH levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Free Thyroxine Level
時間枠：Baseline, 2 months, and 6 months
Serum free thyroxine (free T4) will be measured in ng/dL to assess thyroid function. Mean free T4 levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Total Cholesterol Level
時間枠：Baseline, 2 months, and 6 months
Serum total cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Low-Density Lipoprotein Cholesterol Level
時間枠：Baseline, 2 months, and 6 months
Serum low-density lipoprotein (LDL) cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean High-Density Lipoprotein Cholesterol Level
時間枠：Baseline, 2 months, and 6 months
Serum high-density lipoprotein (HDL) cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Mean Triglyceride Level
時間枠：Baseline, 2 months, and 6 months
Serum triglycerides will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Baseline, 2 months, and 6 months
Incidence of All-Cause Mortality
時間枠：From enrollment to the end of the study at 6 months
Number and proportion of participants who die from any cause during study participation, assessed through medical record review and/or family report.
From enrollment to the end of the study at 6 months
Incidence of Cardiovascular Events
時間枠：From enrollment to the end of the study at 6 months
Number and proportion of participants experiencing one or more cardiovascular events, including acute myocardial infarction, atrial fibrillation, stroke, acute coronary syndrome, or heart failure, assessed through medical record review and participant report.
From enrollment to the end of the study at 6 months
Incidence of Falls and Fractures
時間枠：From enrollment to the end of the study at 6 months
Number and proportion of participants experiencing one or more falls or fractures, assessed through medical record review and participant report.
From enrollment to the end of the study at 6 months
Incidence of Overt Hypothyroidism
時間枠：2 months and 6 months
Number and proportion of participants who develop overt hypothyroidism based on protocol-defined thyroid hormone criteria.
2 months and 6 months
Incidence of Hyperthyroidism
時間枠：2 months and 6 months
Number and proportion of participants who develop hyperthyroidism based on protocol-defined thyroid hormone criteria.
2 months and 6 months
Proportion of Participants Maintaining Euthyroid Status After Levothyroxine Discontinuation
時間枠：2 months and 6 months
Among participants randomized to levothyroxine discontinuation/placebo, the number and proportion who remain euthyroid based on protocol-defined thyroid hormone criteria will be assessed.
2 months and 6 months
Number of Participants with Adverse Events
時間枠：From enrollment to 30 days after Month 6
Number and proportion of participants experiencing one or more adverse events during study participation. Adverse events will be assessed and classified according to the protocol-defined criteria for severity, expectedness, and relationship to study intervention.
From enrollment to 30 days after Month 6
Number of Participants with Serious Adverse Events
時間枠：From enrollment to 30 days after Month 6
Number and proportion of participants experiencing one or more serious adverse events as defined in the study protocol.
From enrollment to 30 days after Month 6

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Spyridoula Maraka

捜査官

  • スタディディレクター：Spyridoula Maraka, M.D., M.S.、Central Arkansas Veterans Healthcare System

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年10月1日

一次修了 (推定)

2030年9月1日

研究の完了 (推定)

2031年9月1日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月21日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • LT4-DISCONTINUE-01

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米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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