Status:
RECRUITING
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid; Functional Disturbance
Hypothyroidism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 no...
Detailed Description
Data spanning over three decades show that hypothyroidism is highly prevalent in the chronic kidney disease (CKD) population, affecting 25% of those receiving dialysis therapy. In the general populati...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT03977207
Start Date
July 20 2020
End Date
November 30 2025
Last Update
September 8 2025
Active Locations (1)
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1
University of California Irvine
Orange, California, United States, 92868