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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.
 
ClinicalTrials.gov Identifier: NCT01950260
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 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
Actual Study Start Date : September 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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. Number of Participants With Overt Hypothyroidism [ Time Frame: 8 weeks ]
    Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result > 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) < 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.


Secondary Outcome Measures :
  1. Change in Hypothyroid-Health Related Quality of Life [ Time Frame: 4 weeks, 8 weeks ]
    The mean change in Quality of life scores was measured by the Hypothyroid-Health Related Quality of Life (HRQL) questionnaire. This questionnaire consists of 27 questions specifying the severity of the discomfort or symptoms of hypothyroidism using a 5 point scale for each question with "not at all"=1 to "all the time"=5. Higher scores are associated with a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.

  2. Change in Thyroid Specific Quality of Life [ Time Frame: 4 weeks, 8 weeks ]
    The mean change in quality of life scores was measured by the Thyroid Specific Questionnaire (TSQ). This questionnaire consists of 12 questions ranked on a four-point scale for each question where 0 is 'better than usual' and 3 is 'much less than usual'. A higher score indicates higher levels of dissatisfaction and a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.



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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
Criteria

Inclusion criteria:

-all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD

Exclusion criteria:

  • clinically manifest Graves' ophthalmopathy (GO)
  • recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
  • preexistent cardiomyopathy
  • malnutrition
  • psychiatric history that could get worse if patient remains persistently hyperthyroid
  • unlikely to return for the planned follow-up visits
  • unlikely to comply with the blood drawing schedule
  • unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires

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 ClinicalTrials.gov identifier (NCT number): NCT01950260


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Marius Stan, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Marius Stan, Mayo Clinic:
Additional Information:
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Responsible Party: Marius Stan, Associate Professor of Medicine, Endocrinology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01950260    
Other Study ID Numbers: 13-002570
First Posted: September 25, 2013    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019
Last Verified: October 2019
Keywords provided by Marius Stan, Mayo Clinic:
Graves' disease
Radioactive iodine
Hypothyroidism
Additional relevant MeSH terms:
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Graves Disease
Thyroid Diseases
Endocrine System Diseases
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs