Phase 3
N=61
Early Levothyroxine Post Radioactive Iodine
Graves' Disease
Bottom Line
View on ClinicalTrials.gov: NCT01950260 ↗Enrolled (actual)
61
Serious AEs
1.6%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Overt Hypothyroidism — 11; 17 Participants — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levothyroxine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overt Hypothyroidism |
11; 17 | 0.23 |
| SECONDARY Change in Hypothyroid-Health Related Quality of Life |
12; 19.8 | 0.41 |
| SECONDARY Change in Thyroid Specific Quality of Life |
-2; -3.8 | 0.33 |
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).
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
Data sourced from ClinicalTrials.gov (NCT01950260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.