Actively Recruiting
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Led by University of California, Irvine · Updated on 2025-09-08
336
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old
- Receiving hemodialysis for at least four weeks
- Two consecutive TSH levels between >3.0 and 10.0 mIU/L during screening
- Normal free thyroxine (FT4) levels
- Ability to provide written informed consent
You will not qualify if you...
- Currently receiving thyroid hormone supplementation or anti-thyroid medications
- Currently receiving dialysis treatment
- Prior kidney transplantation
- Life expectancy less than six months
- Active cancer or previous thyroid cancer
- Currently pregnant or planning pregnancy
- Active coronary ischemia or atrial fibrillation
- Active congestive heart failure flare-up
- Osteoporosis
- Weight over 450 pounds
- Hyperthyroidism (TSH <0.5 mIU/L), anti-thyroid medication use, or hyperthyroidism diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Connie Rhee, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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