Thyroid hormone supplementation for patients on hemodialysis
Official title: A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Run by University of California, Irvine · NCT03977207 · Data updated 2026-11-12
This study is testing if a thyroid hormone pill can help people on hemodialysis with mild thyroid issues feel better and improve their heart health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 336 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Status | Recruiting |
| Started | July 20, 2020 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT03977207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 who have been on hemodialysis for at least four weeks and have elevated TSH levels between 3.0-10.0 mIU/L.
✕Probably not a fit
Patients currently receiving thyroid hormone treatment, those with certain cardiovascular conditions, or those with a life expectancy of less than six months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of levothyroxine, a thyroid hormone, on hemodialysis patients who have high-normal or subclinical hypothyroidism. The study aims to determine whether levothyroxine can improve health-related quality of life, cardiovascular outcomes, and metabolic effects in this population. It will involve a randomized, double-blind, placebo-controlled design with 336 participants receiving either the medication or a placebo. The trial will assess various health metrics, including physical performance and cardiovascular function, to evaluate the efficacy of thyroid hormone replacement.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and cardiovascular health for hemodialysis patients suffering from hypothyroidism.
How similar studies have gone: While there is limited data on the efficacy of levothyroxine in hemodialysis patients, previous studies have shown associations between elevated TSH levels and adverse health outcomes, indicating a potential for significant findings in this area.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California Irvine
Orange, California, United States Recruiting
Study contacts
- Study coordinator: Connie Rhee, MD, MSc
- Email: crhee1@uci.edu
- Phone: 714-456-5142
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.