Home › Thyroid Diseases › NCT03977207
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age 18-75 years old * Received hemodialysis at least four weeks * Have two consecutive thyrotropin (TSH) levels \>3.0-10.0mIU/L during the screening period * Have normal free thyroxine (FT4) levels * Have ability to provide written informed consent Exclusion Criteria: * Active treatment with thyroid hormone supplementation or anti-thyroid medications * Active receipt of dialysis * Prior kidney transplantation * Life expectancy less than six months * Active malignancy or prior thyroid malignancy * Active pregnancy or planning a pregnancy * Active coronary ischemia or atrial fibrillation (evaluated by EKG) * Active congestive heart failure exacerbation * Osteoporosis * Weight in excess of 450 lbs. * Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis
About the study
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.
What is being tested
- Levothyroxine Sodium (drug)
- Placebos (drug)
Sponsor: University of California, Irvine · Participants: 336 · Started: Jul 20, 2020
Contact the study team
- Connie Rhee, MD, MSc · Phone: 714-456-5142
Official record on ClinicalTrials.gov — NCT03977207
Locations in the U.S.
| California | University of California Irvine, Orange |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.