A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Not Applicable

• Conditions: Kidney Diseases, Chronic; Thyroid Disease
• Interventions: Drug: Placebo Oral Tablet; Drug: Levothyroxine Sodium

• Registration Number: NCT03191188
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-07-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	-
Levothyroxine	Levothyroxine Sodium	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Triceps skinfold	Baseline and 12 weeks	Change in triceps skinfold
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
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
Mid-arm circumference	Baseline and 12 weeks	Change in mid-arm circumference
Subjective Global Assessment questionnaire	Baseline and 12 weeks	Subjective Global Assessment questionnaire score
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

Trial Locations

Locations (1)

University Dialysis Center of Orange; 🇺🇸 Orange, California, United States