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

2026년 8월 21일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

138

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Central Arkansas Veterans Healthcare System
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Spyridoula Maraka, M.D., M.S.
    • Florida
      • Gainesville, Florida, 미국, 32610
        • University of Florida Clinical Research Center
        • 연락하다:
        • 수석 연구원:
          • Naykky Singh Ospina, M.D., M.S.
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic
        • 연락하다:
          • Juan Pablo Brito Campana, M.B.B.S.
          • 전화번호: (507) 266-0500
          • 이메일: brito.juan@mayo.edu
        • 수석 연구원:
          • Juan Pablo Brito Campana, M.B.B.S.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Levothyroxine Continuation
Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
의약품: 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.
실험적: Levothyroxine Discontinuation
Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Spyridoula Maraka

수사관

  • 연구 책임자: Spyridoula Maraka, M.D., M.S., Central Arkansas Veterans Healthcare System

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 10월 1일

기본 완료 (추정된)

2030년 9월 1일

연구 완료 (추정된)

2031년 9월 1일

연구 등록 날짜

최초 제출

2026년 8월 11일

QC 기준을 충족하는 최초 제출

2026년 8월 21일

처음 게시됨 (실제)

2026년 8월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 21일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LT4-DISCONTINUE-01

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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아니

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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