Early Levothyroxine Post Radioactive Iodine


  • Study type

  • Study phase

  • Study IDs

  • 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.
  • 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.

  • Site IRB
    • 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).

Participation eligibility

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

Inclusion Criteria:

  •  All adult patients (ages 18-70 years)
  •  With Graves' Disease
  •  Who will receive RAI for treatment of GD

Exclusion Criteria:

  • Patients with clinically manifest Graves’ Ophthalmopathy
  • Patients with recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
  • Preexistent cardiomyopathy
  • Malnutrition
  • 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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Open for enrollment

Contact information:

Jeanette Laugen




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