NCT06073665 Dosing of LT4 in Older Individuals
| NCT ID | NCT06073665 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Pennsylvania |
| Condition | Hypothyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 228 participants in total. It began in 2024-01-31 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
Eligibility 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.
Contact & Investigator
Anne R. Cappola, M.D., Sc.M.
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06073665 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Hypothyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06073665 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06073665 currently recruiting?
Yes, NCT06073665 is actively recruiting participants. Contact the research team at acappola@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06073665 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06073665 clinical trial?
NCT06073665 is sponsored by University of Pennsylvania. The principal investigator is Anne R. Cappola, M.D., Sc.M. at University of Pennsylvania. The trial plans to enroll 228 participants.