Early Levothyroxine Post Radioactive Iodine

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01950260
First received: September 23, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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
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: June 2015
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950260

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paula Giesler, RN    507-255-8345    Giesler.Paula@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Marius Stan, MD Mayo Clinic
  More Information

No publications provided

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: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Graves' disease
Radioactive iodine
Hypothyroidism

Additional relevant MeSH terms:
Graves Disease
Hypothyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014