Early Levothyroxine Post Radioactive Iodine
|ClinicalTrials.gov Identifier: NCT01950260|
Recruitment Status : Unknown
Verified May 2016 by Marius Stan, Mayo Clinic.
Recruitment status was: Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Drug: Levothyroxine Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
U.S. FDA Resources
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.
Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
Other Name: Thyroid hormone
Placebo Comparator: 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.
Placebo to start at 4 weeks after RAI
- Prevention of overt hypothyroidism [ Time Frame: 8 weeks ]Incidence of overt hypothyroidism at 8 weeks post RAI (TSH > 3.0 mIU/L or fT4 < 0.8 ng/dL)
- Quality of Life [ Time Frame: 8 weeks and 6 months ]Quality of Life measured by the hypothyroid-HRQL and the TSQ at 8 weeks and 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950260
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Marius Stan, MD||Mayo Clinic|