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

Conditions

• Hypothyroidism

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Levothyroxine Pill — DRUG
  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.
• Placebo — DRUG
  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 Details

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.

Key Dates

First listed

Aug 26, 2026

Start date

Oct 31, 2027

Status verified

Aug 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2031

Study Design

Enrollment

138 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Levothyroxine Continuation
  Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
• Experimental: Levothyroxine Discontinuation
  Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.

Primary Outcome Measure

Mean ThyPRO Hypothyroid Symptoms Scale Score at 6 Months [ Time Frame: 6 months ]

Central Contacts

• Spyridoula Maraka, M.D., M.S.
  (501) 257-5848
  [email protected]
• Katherine Dishongh
  (501) 507-9554
  [email protected]

Locations (3)

Find similar trials in Little Rock, AR

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