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RECRUITING
NCT03977207
NA

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2020-07-20

Completion Date

2025-11-30

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DRUG

Levothyroxine Sodium

Thyroid hormone supplement

DRUG

Placebos

Placebo oral capsule

Locations (1)

University of California Irvine

Orange, California, United States