Thyroid hormone supplementation for patients on hemodialysis
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT03977207 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orange, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.