Early Levothyroxine Post Radioactive Iodine
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graves' Disease
Intervention: Levothyroxine (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Marius Stan, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Jeanette Laugen, Phone: 507-255-8110, Email: laugen.jeanette@mayo.edu
Summary
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).
Clinical Details
Official title: Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Prevention of overt hypothyroidism
Secondary outcome: Quality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Jeanette Laugen, Phone: 507-255-8110, Email: laugen.jeanette@mayo.edu
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Paula Giesler, RN, Phone: 507-255-8345, Email: Giesler.Paula@mayo.edu
Additional Information
Starting date: September 2013
Last updated: November 30, 2014
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