Early Levothyroxine Post Radioactive Iodine
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Start date||September 2013|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01950260, 13-002570|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Prevention of overt hypothyroidism
time frame: 8 weeks
Quality of Life
time frame: 8 weeks and 6 months
Male or female participants from 18 years up to 70 years old.
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.
|Official title||Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease|
|Principal investigator||Marius Stan, MD|
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