RECRUITING

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.

Official Title

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Quick Facts

Study Start:2020-07-20
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03977207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-75 years old
  2. * Received hemodialysis at least four weeks
  3. * Have two consecutive thyrotropin (TSH) levels \>3.0-10.0mIU/L during the screening period
  4. * Have normal free thyroxine (FT4) levels
  5. * Have ability to provide written informed consent
  1. * Active treatment with thyroid hormone supplementation or anti-thyroid medications
  2. * Active receipt of dialysis
  3. * Prior kidney transplantation
  4. * Life expectancy less than six months
  5. * Active malignancy or prior thyroid malignancy
  6. * Active pregnancy or planning a pregnancy
  7. * Active coronary ischemia or atrial fibrillation (evaluated by EKG)
  8. * Active congestive heart failure exacerbation
  9. * Osteoporosis
  10. * Weight in excess of 450 lbs.
  11. * Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis

Contacts and Locations

Study Contact

Connie Rhee, MD, MSc
CONTACT
714-456-5142
crhee1@uci.edu

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-20
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-07-20
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Thyroid; Functional Disturbance
  • Hypothyroidism
  • Hemodialysis