A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Key facts
- Where
- Orange, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT03977207, who can take part
Where in United States
- University of California IrvineOrange, United StatesContact: Kamyar Kalantar-ZadehTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of California, Irvine
- Trial code
- NCT03977207
- Record updated
- 8 September 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Active treatment with thyroid hormone supplementation or anti-thyroid medications; Prior kidney transplantation; Active malignancy or prior thyroid malignancy; Hyperthyroidism as determined by TSH <0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis; Active congestive heart failure exacerbation; Active receipt of dialysis; Life expectancy less than six months; Active pregnancy or planning a pregnancy; Active coronary ischemia or atrial fibrillation (evaluated by EKG); Osteoporosis; Weight in excess of 450 lbs.