Recruiting

Thyroid Hormone Replacement

Sponsor:

UCLA

Code:

NCT03191188

Conditions

Thyroid Disease

Kidney Diseases, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Levothyroxine Sodium

Placebo Oral Tablet

Study Details

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.

Conditions

Thyroid Disease

Kidney Diseases, Chronic

Study ID

NCT03191188

Start date

Jul 1, 2017

Status verified date

Jun, 2021

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Levothyroxine

placebo comparator: Placebo

Interventions

Levothyroxine Sodium

Thyroid hormone supplement

Placebo Oral Tablet

Placebo

Primary outcome measure

  • Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Connie M. Rhee, MD, MSc

714-456-5142crhee1@uci.edu

Locations

University Dialysis Center of Orange

Recruiting

Orange, California, United States, 92868

Contacts

Kamyar Kalantar-Zadeh, MD, MPH, PhD

714-634-3583kkz@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jun 14, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2021-06-14.