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

ConditionHypothyroidism
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorSpyridoula Maraka

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Levothyroxine ContinuationActive comparator 1 intervention
Group B: Levothyroxine DiscontinuationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
Baseline, 2 months, 6 months
2

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.

Time frame
Baseline, 2 month, and 6 months
3

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.

Time frame
Baseline, 2 months, and 6 months
4

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.

Time frame
Baseline, 2 months, and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spyridoula Maraka

Lead sponsor

Biomedical Research Foundation

Sponsor institution

Source ClinicalTrials.gov

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