Graves' Disease | Early Levothyroxine Post Radioactive Iodine
Graves' Disease research study
What is the primary objective of 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).
Who is eligible to participate?
Inclusion criteria target all adult patients (ages 18-70 years) with GD who will receive RAI for treatment of GD. Patient with clinically manifest GO will be excluded from the study. We will also exclude patients with recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias, those with preexistent cardiomyopathy, those with malnutrition and those with 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 will also be excluded.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LevothyroxineEarly initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
Other:PlaceboPlacebo to start at 4 weeks after RAI
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LevothyroxineIn the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.
PlaceboIn the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.
Start Date: September 2013
Completed Date: December 2016
Phase: Phase 2/Phase 3
Primary Outcome: Prevention of overt hypothyroidism
Secondary Outcome: Quality of Life
Study sponsors, principal investigator, and references
Principal Investigator: Marius Stan, MD
Lead Sponsor: Mayo Clinic