HypothyroidismPhase 4NCT07787585
Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism
A Phase 4 study testing Levothyroxine Pill in people with Hypothyroidism, run by Spyridoula Maraka at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2027to Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years.
- Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range.
- Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months.
- Receiving levothyroxine at a dose ≤50 mcg/day, or ≤25 mcg/day for participants weighing <50 kg.
- 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.
Who cannot join
- TSH >10 mIU/L at any time documented in the institutional electronic health record.
- Levothyroxine therapy initiated less than 6 months before enrollment.
- Abnormal thyroid function at the time of enrollment.
- Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium.
- History of thyroid cancer or goiter with compressive symptoms.
- History of partial or total thyroidectomy or radioactive iodine therapy.
Show all 16Show fewer
- New York Heart Association (NYHA) Class IV heart failure.
- Hospitalization for a major illness or elective surgery within the previous 4 weeks, including acute coronary syndrome, acute myocarditis, pancarditis, or stroke.
- Unstable medical condition that, in the investigator's judgment, would jeopardize participant safety or interfere with study participation.
- Terminal illness with a life expectancy of less than 6 months.
- Lack of decision-making capacity.
- Severe dyslipidemia, defined as LDL cholesterol >190 mg/dL.
- Untreated depression.
- Uncontrolled psychiatric disorder.
- Uncontrolled chronic fatigue syndrome.
- Uncontrolled pain.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Florida Clinical Research Center
Gainesville, Florida, 32610
Naykky Singh Ospina, M.D., M.S., (352) 273-8655, naykky.singhospina@medicine.ufl.edu
Naykky Singh Ospina, M.D., M.S.
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
Spyridoula Maraka, M.D., M.S., (501) 257-5848, spyridoula.maraka@va.gov
Katherine Dishongh, (501) 507-9554, katherine.dishongh@va.gov
Mayo Clinic
Rochester, Minnesota, 55905
Juan Pablo Brito Campana, M.B.B.S., (507) 266-0500, brito.juan@mayo.edu
Juan Pablo Brito Campana, M.B.B.S.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine Pill, Placebo
- Keywords
- subclinical hypothyroidism, levothyroxine, deprescribing, thyroid-related symptoms, older adults
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine PillDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine Continuation | Active comparator | Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication. Receives: Drug: Levothyroxine Pill |
| Levothyroxine Discontinuation | Experimental | Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ThyPRO Hypothyroid Symptoms Scale Score at 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.
Measured: 6 months
Secondary outcomes (24)
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
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.
Measured: Baseline, 2 months, 6 months
Mean ThyPRO Tiredness Scale Score
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.
Measured: Baseline, 2 month, and 6 months
Mean Brief Fatigue Inventory Score
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.
Measured: Baseline, 2 months, and 6 months
Mean Patient-Generated Index Visual Analogue Scale Score
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.
Measured: Baseline, 2 months, and 6 months
Mean ThyPRO-39 Quality-of-Life Score
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.
Measured: Baseline and 6 months
Mean EQ-5D Descriptive Index Score
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.
Measured: Baseline, 2 months, and 6 months
Mean EQ Visual Analogue Scale Score
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.
Measured: Baseline, 2 months, and 6 months
Number of Participants Preferring Study Treatment Versus Pre-Study Treatment
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.
Measured: 2 months and 6 months
Mean Modified Telephone Interview for Cognitive Status Score
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.
Measured: Baseline and 6 months
Mean Body Weight
Body weight will be measured in kilograms. Mean body weight and change in body weight will be compared between treatment groups.
Measured: Baseline, 2 months, and 6 months
Mean Thyroid-Stimulating Hormone Level
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.
Measured: Baseline, 2 months, and 6 months
Mean Free Thyroxine Level
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.
Measured: Baseline, 2 months, and 6 months
Mean Total Cholesterol Level
Serum total cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Measured: Baseline, 2 months, and 6 months
Mean Low-Density Lipoprotein Cholesterol Level
Serum low-density lipoprotein (LDL) cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Measured: Baseline, 2 months, and 6 months
Mean High-Density Lipoprotein Cholesterol Level
Serum high-density lipoprotein (HDL) cholesterol will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Measured: Baseline, 2 months, and 6 months
Mean Triglyceride Level
Serum triglycerides will be measured in mg/dL. Mean levels and longitudinal changes will be compared between treatment groups.
Measured: Baseline, 2 months, and 6 months
Incidence of All-Cause Mortality
Number and proportion of participants who die from any cause during study participation, assessed through medical record review and/or family report.
Measured: From enrollment to the end of the study at 6 months
Incidence of Cardiovascular Events
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.
Measured: From enrollment to the end of the study at 6 months
Incidence of Falls and Fractures
Number and proportion of participants experiencing one or more falls or fractures, assessed through medical record review and participant report.
Measured: From enrollment to the end of the study at 6 months
Incidence of Overt Hypothyroidism
Number and proportion of participants who develop overt hypothyroidism based on protocol-defined thyroid hormone criteria.
Measured: 2 months and 6 months
Incidence of Hyperthyroidism
Number and proportion of participants who develop hyperthyroidism based on protocol-defined thyroid hormone criteria.
Measured: 2 months and 6 months
Proportion of Participants Maintaining Euthyroid Status After Levothyroxine Discontinuation
Among participants randomized to levothyroxine discontinuation/placebo, the number and proportion who remain euthyroid based on protocol-defined thyroid hormone criteria will be assessed.
Measured: 2 months and 6 months
Number of Participants with Adverse Events
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.
Measured: From enrollment to 30 days after Month 6
Number of Participants with Serious Adverse Events
Number and proportion of participants experiencing one or more serious adverse events as defined in the study protocol.
Measured: From enrollment to 30 days after Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startOct 2027 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spyridoula Maraka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Spyridoula Maraka, Biomedical Research Foundation
- Investigators
- Spyridoula Maraka, M.D., M.S., Study director, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787585
- Sponsor's protocol ID
- LT4-DISCONTINUE-01
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Low Dose Levothyroxine Therapy for Older Adults With Subclinical Hypothyroidism: a Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07787585
- Acronym / sponsor ID
- LT4-DISCONTINUE-01
- Conditions
- Hypothyroidism
- Keywords
- subclinical hypothyroidism, levothyroxine, deprescribing, thyroid-related symptoms, older adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Spyridoula MarakaUniversity, hospital or other
- Study start
- Oct 2027 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine Continuation | Active comparator | Drug: Levothyroxine PillParticipants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication. |
| Levothyroxine Discontinuation | Experimental | Drug: PlaceboParticipants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥65 years.
- Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range.
- Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months.
- Receiving levothyroxine at a dose ≤50 mcg/day, or ≤25 mcg/day for participants weighing <50 kg.
- Receiving outpatient care at the participating study site for at least 12 months.
Key exclusion criteria (16 listed)
- TSH >10 mIU/L at any time documented in the institutional electronic health record.
- Levothyroxine therapy initiated less than 6 months before enrollment.
- Abnormal thyroid function at the time of enrollment.
- Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium.
- History of thyroid cancer or goiter with compressive symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxine PillParticipants 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. | Drug | Levothyroxine Continuation |
| PlaceboParticipants 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. | Drug | Levothyroxine Discontinuation |
Primary outcome
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months
Time frame: 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.
24 secondary outcomes
Mean ThyPRO Hypothyroid Symptoms Scale Score Over Time
Time frame: Baseline, 2 months, 6 months
Mean ThyPRO Tiredness Scale Score
Time frame: Baseline, 2 month, and 6 months
Mean Brief Fatigue Inventory Score
Time frame: Baseline, 2 months, and 6 months
Mean Patient-Generated Index Visual Analogue Scale Score
Time frame: Baseline, 2 months, and 6 months
Mean ThyPRO-39 Quality-of-Life Score
Time frame: Baseline and 6 months
Mean EQ-5D Descriptive Index Score
Time frame: Baseline, 2 months, and 6 months
Mean EQ Visual Analogue Scale Score
Time frame: Baseline, 2 months, and 6 months
Number of Participants Preferring Study Treatment Versus Pre-Study Treatment
Time frame: 2 months and 6 months
Mean Modified Telephone Interview for Cognitive Status Score
Time frame: Baseline and 6 months
Mean Body Weight
Time frame: Baseline, 2 months, and 6 months
Mean Thyroid-Stimulating Hormone Level
Time frame: Baseline, 2 months, and 6 months
Mean Free Thyroxine Level
Time frame: Baseline, 2 months, and 6 months
Mean Total Cholesterol Level
Time frame: Baseline, 2 months, and 6 months
Mean Low-Density Lipoprotein Cholesterol Level
Time frame: Baseline, 2 months, and 6 months
Mean High-Density Lipoprotein Cholesterol Level
Time frame: Baseline, 2 months, and 6 months
Mean Triglyceride Level
Time frame: Baseline, 2 months, and 6 months
Incidence of All-Cause Mortality
Time frame: From enrollment to the end of the study at 6 months
Incidence of Cardiovascular Events
Time frame: From enrollment to the end of the study at 6 months
Incidence of Falls and Fractures
Time frame: From enrollment to the end of the study at 6 months
Incidence of Overt Hypothyroidism
Time frame: 2 months and 6 months
Incidence of Hyperthyroidism
Time frame: 2 months and 6 months
Proportion of Participants Maintaining Euthyroid Status After Levothyroxine Discontinuation
Time frame: 2 months and 6 months
Number of Participants with Adverse Events
Time frame: From enrollment to 30 days after Month 6
Number of Participants with Serious Adverse Events
Time frame: From enrollment to 30 days after Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Spyridoula Maraka, M.D., M.S. study director
Central Arkansas Veterans Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine Pill in people with Hypothyroidism, run by Spyridoula Maraka at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Spyridoula Maraka, M.D., M.S. ((501) 257-5848, spyridoula.maraka@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.