Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Spyridoula Maraka, M.D., M.S.
Principal Investigator
Central Arkansas Veterans Healthcare System
Are You a Good Fit for This Trial?
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will discontinue levothyroxine and receive matching placebo for 6 months using blinded study medication.
Participants will continue their pre-study dose of levothyroxine for 6 months using blinded study medication.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spyridoula Maraka
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.