Overview

This trial is active, not recruiting.

Condition graves' disease
Treatments levothyroxine, placebo
Phase phase 2/phase 3
Sponsor Mayo Clinic
Start date September 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT01950260, 13-002570

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
In 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.
levothyroxine Thyroid hormone
Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
(Placebo Comparator)
In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.
placebo
Placebo to start at 4 weeks after RAI

Primary Outcomes

Measure
Prevention of overt hypothyroidism
time frame: 8 weeks

Secondary Outcomes

Measure
Quality of Life
time frame: 8 weeks and 6 months

Eligibility Criteria

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.

Additional Information

Official title Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Principal investigator Marius Stan, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.