Trial · NCT03977207
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
NCT03977207, Not applicable, Recruiting, University of California, Irvine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients. Trials, record NCT03977207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03977207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
- NCT number
- NCT03977207
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 336 participants, estimated
- Lead sponsor
- University of California, Irvine
- Conditions
- Thyroid; Functional Disturbance, Hypothyroidism, Hemodialysis
- Interventions
- Levothyroxine Sodium, Placebos
- First posted
- 2019-06-06
- Last updated
- 2025-09-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | Week 0 (pre-trial/baseline) | 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. |
| Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | Week 12 | 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. |
| Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | Week 24 | 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. |
| Primary | Coronary Artery Calcification (CAC) - Volume Score | Week 0 (pre-trial/baseline) | We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery). |
| Primary | Coronary Artery Calcification (CAC) - Volume Score | Week 24 | We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery). |
| Secondary | Thyroid-Specific HRQOL - ThyPRO Hypothyroid Symptoms and Tiredness Domain Scores | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | We will administer the thyroid-specific quality of life patient-reported outcome (ThyPRO) measure, which is comprised of 84 items categorized into 13 domains, plus a general quality of life question (this is a composite measure). |
| Secondary | Physical Performance - Short Physical Performance Battery (SPPB) | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | We will measure physical performance using the Short Physical Performance Battery (SPPB), which tests 1) gait speed (faster of two timed, usual pace 15-foot walks), 2) balance (balance test measuring ability to stand with feet in side-by-side, semi-tandem, and tandem positions for 10 seconds), and 3) chair raises (timed series of five attempts to arise from a chair unassisted without use of arms), with each component ranging from 0 to 4 (score 0-12; higher score indicates better performance). |
| Secondary | Endothelial Function - Digital Thermal Monitor | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | We will measure endothelial function using digital thermal monitor (DTM) testing, which is based on the principle that changes in fingertip temperature during and after an ischemic stimulus (blood pressure \[BP\] cuff occlusion) reflect changes in blood flow. In normal endothelial function, cuff inflation results in a 1-3 degree Celsius temperature decline, followed by rapid temperature rise to above baseline during cuff deflation due to compensatory vasodilation. Temperature (temp) will be measured before, during, and after a 2-minute BP cuff inflation in the non-vascular access arm in order to measure Area Under the Temp Curve (TMP-AUC), defined as area under the curve between the maximum and minimum temp. |
| Secondary | Vascular Calcification Inhibitor - Matrix Gla Protein Levels | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | We will use plasma collected during hemodialysis treatments to measure total uncarboxylated matrix Gla protein levels. Assays will be conducted in the University of California Irvine Institute of Clinical Translational Science Bioassay Core. |
| Secondary | Total Body Fat Percentage | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | We will assess total body fat percentage using Dual Energy X-Ray absorptiometry. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03977207
GET https://conductscience.org/api/trials/v1/NCT03977207/registered