Early Levothyroxine Post Radioactive Iodine
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II/III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-002570
NCT ID: NCT01950260
Sponsor Protocol Number: 13-002570
About this study
The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves' disease will prevent overt hypothyroidism (low thyroid hormone levels).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- All adult patients (ages 18-70 years)
- With Graves' Disease
- Who will receive RAI for treatment of GD
- Patients with clinically manifest Graves’ Ophthalmopathy
- Patients with recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
- Preexistent cardiomyopathy
- Psychiatric history that could get worse if patient remains persistently hyperthyroid
- Patients unlikely to return for the planned follow-up visits, to comply with the blood drawing schedule and with the completion of the hypothyroid-HDQL and TQS questionnaires
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.