Early Levothyroxine Post Radioactive Iodine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

NCT01295333

Graves Disease (Basedow's Disease)

COMPLETED PHASE3

Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease

NCT05643365

Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients

UNKNOWN

Block-replacement Therapy During Radioiodine Therapy

NCT00150124

Toxic Nodular Goitre Graves' Disease

COMPLETED PHASE4

Desiccated Thyroid Extract Versus Synthetic T3/T4 Combination (ThyrolarTM) Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism

NCT02317926

Hypothyroidism

UNKNOWN NA

Novel Approaches to the Treatment of Hypothyroidism

NCT06731764

Hypothyroidism

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graves' Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to start at 4 weeks after RAI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levothyroxine

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

Intervention Type DRUG

Placebo

Placebo to start at 4 weeks after RAI

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thyroid hormone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No