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

21 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

138

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Central Arkansas Veterans Healthcare System
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Spyridoula Maraka, M.D., M.S.
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida Clinical Research Center
        • Contatto:
        • Investigatore principale:
          • Naykky Singh Ospina, M.D., M.S.
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
        • Contatto:
          • Juan Pablo Brito Campana, M.B.B.S.
          • Numero di telefono: (507) 266-0500
          • Email: brito.juan@mayo.edu
        • Investigatore principale:
          • Juan Pablo Brito Campana, M.B.B.S.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Levothyroxine Continuation
Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
Droga: 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.
Sperimentale: Levothyroxine Discontinuation
Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Spyridoula Maraka

Investigatori

  • Direttore dello studio: Spyridoula Maraka, M.D., M.S., Central Arkansas Veterans Healthcare System

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2027

Completamento primario (Stimato)

1 settembre 2030

Completamento dello studio (Stimato)

1 settembre 2031

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2026

Primo Inserito (Effettivo)

26 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LT4-DISCONTINUE-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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