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A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Sponsor: University of California, Irvine
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2020-07-20
Completion Date
2025-11-30
Last Updated
2025-09-08
Healthy Volunteers
No
Interventions
Levothyroxine Sodium
Thyroid hormone supplement
Placebos
Placebo oral capsule
Locations (1)
University of California Irvine
Orange, California, United States