Early Levothyroxine Post Radioactive Iodine

Graves' Disease Clinical Trial

Official title:

Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950260
• Other study ID #: 13-002570
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2013
• Est. completion date: April 2017

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease

Intervention

Drug:
• Levothyroxine
Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).

Other:
• Placebo
Placebo to start at 4 weeks after RAI

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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.	4 weeks, 8 weeks
Secondary	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.	4 weeks, 8 weeks

External Links

•   Mayo Clinic Clinical Trials