Early Levothyroxine Post Radioactive Iodine

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic
ClinicalTrials.gov Identifier:
First received: September 23, 2013
Last updated: May 13, 2016
Last verified: May 2016
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).

Condition Intervention Phase
Graves' Disease
Drug: Levothyroxine
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Prevention of overt hypothyroidism [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Incidence of overt hypothyroidism at 8 weeks post RAI (TSH > 3.0 mIU/L or fT4 < 0.8 ng/dL)

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 8 weeks and 6 months ] [ Designated as safety issue: No ]
    Quality of Life measured by the hypothyroid-HRQL and the TSQ at 8 weeks and 6 months

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levothyroxine
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.
Drug: Levothyroxine
Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
Other Name: Thyroid hormone
Placebo Comparator: Placebo
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.
Other: Placebo
Placebo to start at 4 weeks after RAI


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01950260

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Marius Stan, MD Mayo Clinic
  More Information

Responsible Party: Marius Stan, Assistant Professor of Medicine, Endocrinology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01950260     History of Changes
Other Study ID Numbers: 13-002570 
Study First Received: September 23, 2013
Last Updated: May 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Graves' disease
Radioactive iodine

Additional relevant MeSH terms:
Graves Disease
Autoimmune Diseases
Endocrine System Diseases
Eye Diseases
Immune System Diseases
Orbital Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on May 26, 2016