A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Study Overview
=================
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.

Official Title
-----------------
A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Conditions
-----------------
Thyroid Disease, Kidney Diseases, Chronic

Intervention / Treatment
-----------------
* Drug: Levothyroxine Sodium
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levothyroxine<br> | Drug: Levothyroxine Sodium<br>* Thyroid hormone supplement<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Oral Tablet<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L | Number of patients achieving target TSH levels of 0.5-3.0mIU/L | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life Short Form 36 questionnaire | Change in Short Form 36 score | Baseline and 12 weeks | 
| Serum Growth Differentiation Factor 15 (GDF15) level | Change in GDF15 level | Baseline and 12 weeks | 
| Serum soluble p-selectin level | Change in soluble p-selectin level | Baseline and 12 weeks | 
| Serum soluble CD40 ligand level | Change in serum soluble CD40 ligand level | Baseline and 12 weeks | 
| Body mass index | Change in body mass index | Baseline and 12 weeks | 
| Biceps skinfold | Change in biceps skinfold | Baseline and 12 weeks | 
| Triceps skinfold | Change in triceps skinfold | Baseline and 12 weeks | 
| Mid-arm circumference | Change in mid-arm circumference | Baseline and 12 weeks | 
| Mid-arm muscle circumference | Change in mid-arm muscle circumference | Baseline and 12 weeks | 
| Near infrared body fat percentage | Change in near infrared body fat percentage | Baseline and 12 weeks | 
| Subjective Global Assessment questionnaire | Subjective Global Assessment questionnaire score | Baseline and 12 weeks |