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NCT03977207 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
A NA study of Hemodialysis and Hypothyroidism, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- NA
- Development phase
- 336
- Enrollment target
- 1
- Study location
NCT03977207: Recruiting NA study of Hemodialysis and Hypothyroidism, sponsored by University of California, Irvine.
NCT03977207 is a NA study of Hemodialysis and Hypothyroidism that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 336 participants, above the 111-participant average among 12 other Hemodialysis trials with a reported enrollment target (203% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03977207, a NA study of Hemodialysis and Hypothyroidism, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- NA
- Development phase
- 336 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Levothyroxine Sodium
Study Locations (1)
California
- University of California Irvine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2025-11-30 |
| Phase | NA |
What NCT03977207 shows while recruiting
NCT03977207 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 111-participant average among 12 other Hemodialysis trials with a reported enrollment target (203% higher).
The record links to 3 conditions, with Hemodialysis appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT03977207 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03977207 about?
NCT03977207 is a clinical study titled "A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients". 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 dise...
What is the current status of trial NCT03977207?
This trial is currently recruiting. It is a NA study. The enrollment target is 336 participants. The study started on 2020-07-20. Estimated completion is 2025-11-30.
What conditions does trial NCT03977207 study?
This clinical trial studies the following conditions: Hemodialysis, Hypothyroidism, Thyroid; Functional Disturbance.
What interventions are being tested in trial NCT03977207?
The interventions under investigation include: Placebos (DRUG), Levothyroxine Sodium (DRUG).
Who is sponsoring clinical trial NCT03977207?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03977207 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemodialysis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03977207's enrollment target sits among peer trials
336 2nd of 12 the highest of 12 other Hemodialysis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemodialysis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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