Flexible dosing of levothyroxine in older adults
Levothyroxine Dosing in Older Individuals
This study is testing if older adults on thyroid medication feel better with a lower or higher target for their thyroid hormone levels over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06073665 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of two different dosing strategies of levothyroxine (LT4) in older individuals aged 65 and above who are already on stable LT4 therapy. Participants will be randomly assigned to either a lower target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L or a higher target of 5.5-7.0 mU/L for a duration of six months. The study will assess various outcomes including symptoms of hypothyroidism, mood, sleep quality, cognitive function, weight, lipid levels, and bone turnover markers.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling individuals aged 65 years and older who have been diagnosed with hypothyroidism and are stable on a specific dose of levothyroxine.
Not a fit: Patients with conditions such as hypopituitarism, thyroid cancer requiring TSH suppression, or those on medications that interfere with thyroid function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypothyroidism in older adults, enhancing their quality of life.
How similar studies have performed: Previous studies have explored levothyroxine dosing strategies, but this specific approach focusing on older adults with flexible TSH targets is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, community dwelling, aged 65 years or older 4. Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test. 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. Adherence to lifestyle considerations. Exclusion Criteria: 1. Hypopituitarism 2. History of thyroid cancer requiring suppression of TSH secretion 3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests 4. GFR \<30 ml/min/1.73 m2 within the prior 12 months 5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded. 6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study. 7. Currently taking multikinase or checkpoint inhibitor therapy. 8. Any history of food dye allergy.
Where this trial is running
Philadelphia, Pennsylvania
- Penn Medicine, Smilow Translational Research Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Anne R. Cappola, M.D., Sc.M. — University of Pennsylvania
- Study coordinator: Anne R. Cappola, M.D., Sc.M.
- Email: acappola@pennmedicine.upenn.edu
- Phone: 215-573-5359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.