Thyroid Status, Quality of Life, and Mental Health in Patients on Hemodialysis.
Connie M Rhee, Yanjun Chen, Amy S You...
https://pubmed.ncbi.nlm.nih.gov/28705886Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID03977207
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
N/A
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
This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin (TSH) levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old
- Received hemodialysis for at least four weeks
- Have two consecutive thyrotropin (TSH) levels between 3.0 and 10.0 mIU/L during screening
- Have normal free thyroxine (FT4) levels
- Able to provide written informed consent
You will not qualify if you...
- Currently receiving thyroid hormone or anti-thyroid medication
- Prior kidney transplant
- Life expectancy less than six months
- Active cancer or prior thyroid cancer
- Active pregnancy or planning pregnancy
- Active coronary ischemia or atrial fibrillation
- Active congestive heart failure flare
- Osteoporosis
- Weight over 450 pounds
- Hyperthyroidism or TSH below 0.5 mIU/L
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants are randomized to receive either levothyroxine or placebo daily for 24 weeks with dose adjustments at weeks 8 and 16 based on thyroid hormone levels.
Visits at baseline, week 8, week 16, and week 24 for dose titrations and assessments
Trial Site Locations
Total: 1 location
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
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Research Team
C
Connie Rhee, MD, MSc
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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Published Research Related To This Trial
Thyroid Status and Mortality in a Prospective Hemodialysis Cohort.
Connie M Rhee, Amy S You, Danh V Nguyen...
https://pubmed.ncbi.nlm.nih.gov/28324018Association of thyroid functional disease with mortality in a national cohort of incident hemodialysis patients.
Connie M Rhee, Steven Kim, Daniel L Gillen...
https://pubmed.ncbi.nlm.nih.gov/25632971Hypothyroidism and mortality among dialysis patients.
Connie M Rhee, Erik K Alexander, Ishir Bhan...
https://pubmed.ncbi.nlm.nih.gov/23258793Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort.
Connie M Rhee, Vanessa A Ravel, Elani Streja...
https://pubmed.ncbi.nlm.nih.gov/27525529Thyroid Status and Death Risk in US Veterans With Chronic Kidney Disease.
Connie M Rhee, Kamyar Kalantar-Zadeh, Vanessa Ravel...
https://pubmed.ncbi.nlm.nih.gov/29728200