A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT03977207
Status
Recruiting
Apply to this trial

Conditions

  • Hemodialysis
  • Hypothyroidism
  • Thyroid; Functional Disturbance

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Levothyroxine Sodium — DRUG
    Thyroid hormone supplement
  • Placebos — DRUG
    Placebo oral capsule

Study Details

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.

Key Dates

Start date
Jul 20, 2020
Status verified
Aug 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Levothyroxine
    Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients will undergo up to two subsequent dose titrations after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points. Patients whose TSH levels are higher or lower than the therapeutic TSH target of 0.5-3.0mIU/L will undergo a dose adjustment (+/- 25mcg), while those whose TSH levels are in target range will continue the prior dose.
  • Placebo Comparator: Placebo
    Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients in the placebo arm will undergo an equivalent titration in placebo pills (as that of the experimental arm) after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points.

Primary Outcome Measure

Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score [ Time Frame: Week 0 (pre-trial/baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868
Kamyar Kalantar-Zadeh
[email protected]
7144565142

Find similar trials in Orange, CA

By research site
University of California Irvine· Orange, CA

Related Studies