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

2026. augusztus 21. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

138

Fázis

  • 4. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Egyesült Államok
    • Arkansas
      • Little Rock, Arkansas, Egyesült Államok, 72205
        • Central Arkansas Veterans Healthcare System
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Spyridoula Maraka, M.D., M.S.
    • Florida
      • Gainesville, Florida, Egyesült Államok, 32610
        • University of Florida Clinical Research Center
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Naykky Singh Ospina, M.D., M.S.
    • Minnesota
      • Rochester, Minnesota, Egyesült Államok, 55905
        • Mayo Clinic
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Juan Pablo Brito Campana, M.B.B.S.

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Hármas

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Aktív összehasonlító: Levothyroxine Continuation
Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
Drog: 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.
Kísérleti: Levothyroxine Discontinuation
Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.
Drog: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Spyridoula Maraka

Nyomozók

  • Tanulmányi igazgató: Spyridoula Maraka, M.D., M.S., Central Arkansas Veterans Healthcare System

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2027. október 1.

Elsődleges befejezés (Becsült)

2030. szeptember 1.

A tanulmány befejezése (Becsült)

2031. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 11.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 21.

Első közzététel (Tényleges)

2026. augusztus 26.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 26.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 21.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • LT4-DISCONTINUE-01

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