A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
University of California, Irvine
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)