A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients (THYROID-HD)
Thyroid; Functional Disturbance, Hypothyroidism, Hemodialysis
About this trial
This is an interventional treatment trial for Thyroid; Functional Disturbance
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
Sites / Locations
- University of California IrvineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Levothyroxine
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 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.
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.