Early Levothyroxine Post Radioactive Iodine
This study is currently recruiting participants.
Verified March 2014 by Mayo Clinic
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic
First received: September 23, 2013
Last updated: March 31, 2014
Last verified: March 2014
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Prevention of overt hypothyroidism [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Incidence of overt hypothyroidism at 8 weeks post RAI (TSH > 3.0 mIU/L or fT4 < 0.8 ng/dL)
Secondary Outcome Measures:
- Quality of Life [ Time Frame: 8 weeks and 6 months ] [ Designated as safety issue: No ]Quality of Life measured by the hypothyroid-HRQL and the TSQ at 8 weeks and 6 months
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950260
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Paula Giesler, RN 507-255-8345 Giesler.Paula@mayo.edu|
Sponsors and Collaborators
|Principal Investigator:||Marius Stan, MD||Mayo Clinic|