Thyroid Disease, Kidney Diseases, Chronic
Conditions
Brief summary
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.
Interventions
Thyroid hormone supplement
DRUGPlacebo Oral Tablet
Placebo
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.
Exclusion criteria
* Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L | 12 weeks | Number of patients achieving target TSH levels of 0.5-3.0mIU/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Growth Differentiation Factor 15 (GDF15) level | Baseline and 12 weeks | Change in GDF15 level |
| Serum soluble p-selectin level | Baseline and 12 weeks | Change in soluble p-selectin level |
| Serum soluble CD40 ligand level | Baseline and 12 weeks | Change in serum soluble CD40 ligand level |
| Body mass index | Baseline and 12 weeks | Change in body mass index |
| Biceps skinfold | Baseline and 12 weeks | Change in biceps skinfold |
| Health-related quality of life Short Form 36 questionnaire | Baseline and 12 weeks | Change in Short Form 36 score |
| Mid-arm circumference | Baseline and 12 weeks | Change in mid-arm circumference |
| Mid-arm muscle circumference | Baseline and 12 weeks | Change in mid-arm muscle circumference |
| Near infrared body fat percentage | Baseline and 12 weeks | Change in near infrared body fat percentage |
| Subjective Global Assessment questionnaire | Baseline and 12 weeks | Subjective Global Assessment questionnaire score |
| Triceps skinfold | Baseline and 12 weeks | Change in triceps skinfold |
Countries
United States
Contacts
Primary ContactConnie M. Rhee, MD, MSc
Outcome results
None listed