NCT03977207 A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
| NCT ID | NCT03977207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Thyroid; Functional Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2020-07-20 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 336 participants in total. It began in 2020-07-20 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03977207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thyroid; Functional Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03977207 currently recruiting?
Yes, NCT03977207 is actively recruiting participants. Contact the research team at crhee1@uci.edu for enrollment information.
Where is the NCT03977207 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT03977207 clinical trial?
NCT03977207 is sponsored by University of California, Irvine. The trial plans to enroll 336 participants.