A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, Irvine

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

336 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Irvine

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator