Could millions of seniors ditch a daily thyroid pill?
NCT ID NCT07787585
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This study asks whether adults aged 65 and older with mild underactive thyroid (subclinical hypothyroidism) can safely stop their low-dose levothyroxine medication. Half the participants will continue their usual levothyroxine, while the other half will receive a placebo for 6 months. Researchers will compare thyroid symptoms, quality of life, and other health measures to see if stopping the drug makes no meaningful difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- levothyroxine
- What this could lead to
- If stopping is safe, many older adults might avoid unnecessary daily medication, reducing costs and side effects.
- What could go wrong
- The trial is small and short-term; stopping may worsen symptoms or thyroid function in some people, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2027
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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University of Florida Clinical Research Center
Gainesville, Florida, 32610, United States
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