Early Levothyroxine Post Radioactive Iodine

Phase 3CompletedNCT01950260

Mayo Clinic61 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Graves' Disease

Interventions

LevothyroxineDRUG

Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).

PlaceboOTHER

Placebo to start at 4 weeks after RAI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 4 weeks, 8 weeks

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.

Time frame: 4 weeks, 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.