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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03977207
The ClinicalTrials.gov registry entry for NCT03977207 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 12 other Hemodialysis trials with a reported enrollment target (203% higher). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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