Back to resultsEarly Levothyroxine Post Radioactive Iodine
Primary Purpose
Graves' Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Graves' Disease focused on measuring Graves' disease, Radioactive iodine, Hypothyroidism
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Levothyroxine
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Overt Hypothyroidism
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
Change in Hypothyroid-Health Related Quality of Life
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.
Change in Thyroid Specific Quality of Life
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01950260
Brief Title
Early Levothyroxine Post Radioactive Iodine
Official Title
Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Disease
Keywords
Graves' disease, Radioactive iodine, Hypothyroidism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Thyroid hormone
Intervention Description
Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to start at 4 weeks after RAI
Primary Outcome Measure Information:
Title
Number of Participants With Overt Hypothyroidism
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Hypothyroid-Health Related Quality of Life
Description
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.
Time Frame
4 weeks, 8 weeks
Title
Change in Thyroid Specific Quality of Life
Description
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.
Time Frame
4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Stan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Early Levothyroxine Post Radioactive Iodine
We'll reach out to this number within 24 hrs