A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jun 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called levothyroxine can help patients on hemodialysis who have hypothyroidism, which is a condition where the thyroid gland doesn’t produce enough hormones. Researchers want to find out if taking this medication can improve patients' quality of life, physical abilities, and heart health. They will also look at how it affects body fat and energy levels.

To participate, individuals need to be between 18 and 75 years old, have been receiving hemodialysis for at least four weeks, and have specific thyroid hormone levels. They should not be currently taking thyroid medication or have certain serious health conditions. If eligible, participants will be part of a study to see if this treatment can make a positive difference in their health and well-being. Overall, this trial aims to gather important information about the safety and effectiveness of thyroid hormone supplementation in dialysis patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-75 years old
• • Received hemodialysis at least four weeks
• • Have two consecutive thyrotropin (TSH) levels \>3.0-10.0mIU/L during the screening period
• • Have normal free thyroxine (FT4) levels
• • Have ability to provide written informed consent
• Exclusion Criteria:
• • Active treatment with thyroid hormone supplementation or anti-thyroid medications
• • Active receipt of dialysis
• • Prior kidney transplantation
• • Life expectancy less than six months
• • Active malignancy or prior thyroid malignancy
• • Active pregnancy or planning a pregnancy
• • Active coronary ischemia or atrial fibrillation (evaluated by EKG)
• • Active congestive heart failure exacerbation
• • Osteoporosis
• • Weight in excess of 450 lbs.
• • Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis