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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

Page last updated: August 23, 2015

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