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ClinicalTrials.gov ID

NCT07787585

Lead Sponsor

Spyridoula MarakaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

138Estimated

Last Update Posted

Aug 26, 2026Actual

Start Date

Oct 2027Estimated

Primary Completion Date

Sep 2030Estimated

Completion Date

Sep 2031Estimated

Official Title

Discontinuation of Low Dose Levothyroxine Therapy for Older Adults With Subclinical Hypothyroidism: a Randomized, Double-blinded, Placebo-controlled Study

Brief 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.

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.

• Hypothyroidism

• Levothyroxine Pill
• Placebo

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Spyridoula MarakaOTHER

brito.juan@mayo.edu(507) 266-0500