About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Active treatment with thyroid hormone supplementation or anti-thyroid medications
Active receipt of dialysis
Prior kidney transplantation
Life expectancy less than six months
Trial design
Treatments tested in this trial
- Levothyroxine Sodium
- Placebos
Treatment groups
Sponsors and collaborators
University of California, Irvine
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator