Early Levothyroxine Post Radioactive Iodine

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Graves' Disease

Treatments: Other: Placebo; Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT01950260

13-002570

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Levothyroxine

Experimental group

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.

Treatment:

Drug: Levothyroxine

Placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo