Early Levothyroxine Post Radioactive Iodine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01950260
Recruitment Status : Unknown
Verified May 2016 by Marius Stan, Mayo Clinic.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : May 17, 2016
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic

Brief 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).

Condition or disease Intervention/treatment Phase
Graves' Disease Drug: Levothyroxine Other: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Study Start Date : September 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Prevention of overt hypothyroidism [ Time Frame: 8 weeks ]
    Incidence of overt hypothyroidism at 8 weeks post RAI (TSH > 3.0 mIU/L or fT4 < 0.8 ng/dL)

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 8 weeks and 6 months ]
    Quality of Life measured by the hypothyroid-HRQL and the TSQ at 8 weeks and 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Marius Stan, Assistant Professor of Medicine, Endocrinology Consultant, Mayo Clinic Identifier: NCT01950260     History of Changes
Other Study ID Numbers: 13-002570
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Marius Stan, Mayo Clinic:
Graves' disease
Radioactive iodine

Additional relevant MeSH terms:
Graves Disease
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs