A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

N/AUnknownNCT03191188

University of California, Irvine96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Thyroid Disease Kidney Diseases, Chronic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 weeks