A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

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.

Conditions

Thyroid; Functional Disturbance, Hypothyroidism, Hemodialysis

Study Overview

Study Details

Study overview

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.

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Condition
Thyroid; Functional Disturbance
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Active treatment with thyroid hormone supplementation or anti-thyroid medications
  • * Active receipt of dialysis
  • * Prior kidney transplantation
  • * Life expectancy less than six months
  • * Active malignancy or prior thyroid malignancy
  • * Active pregnancy or planning a pregnancy
  • * Active coronary ischemia or atrial fibrillation (evaluated by EKG)
  • * Active congestive heart failure exacerbation
  • * Osteoporosis
  • * Weight in excess of 450 lbs.
  • * Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Study Record Dates

2025-04-30