A Phase 2 interventional study of Levothyroxine and Liothyronine in Thyroid Goiter, Hypothyroidism and Thyroid Cancer, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Treatment
The purpose of this research study is to measure the changes in energy metabolism (how the body burns energy), cardiovascular function (heart function), and lipid metabolism (cholesterol break down and building) before and after thyroidectomy (surgical removal of thyroid gland) in response to two approved therapies for hypothyroidism: levothyroxine (LT4) or Liothyronine/levothyroxine (LT3/LT4) combination therapy.
In this study, Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") will be compared to Liothyronine/ Levothyroxine (LT3/LT4) combination therapy.
Levothyroxine LT4 and Liothyronine (LT3) are drugs approved by the U. S. Food and Drug Administration (FDA).
All participants will be required follow VCU Health COVID-19 standard of Care screening procedures.
This study requires approximately five study visits The five-study visits required will be a Screening Visit (outpatient), one Baseline Visit, (inpatient) one Six Week Visit, (outpatient), one Three Month Visit and one Six Month Visit (both inpatient). A COVID-19 test will be done 48 hours (2 days) before each of the three-inpatient visit, Baseline Visit, Three Month and Six Month Visit.
Participants will be asked to:
Participation in this study will last up to 6 months after surgery. Approximately 30 total individuals will participate in this study
66 studies on the registry are indexed under Goiter; 11 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 42 interventional studies indexed under Goiter.
Browse Goiter studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") Patients in the LT4 group will be started at a dose of 1.6 mcg/Kg (52 The VCU Investigational Pharmacy will over-encapsulate LT4 plus placebo, in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation.
Drug: Levothyroxine · Drug: Placebo
Liothyronine/levothyroxine (LT3/LT4) combination therapy. LT4/LT3 group will have 25 mcg of LT4 substituted with 5 mcg LT3 twice daily, to mimic the average daily T3 production form the thyroid The VCU Investigational Pharmacy will over-encapsulate LT4 plus 5 mcg LT3 in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation. No changes will be made in LT3.
Drug: Levothyroxine · Drug: Liothyronine
levothyroxine sodium tablet for oral use
Also known as: L-Thryroxine
Liothyronine sodium tablets for oral use treatment of hypothyroidism
Also known as: Cytomel
inert sugar tablets for oral use blinding for treatment of hypothyroidism
Also known as: Dextrose
Short Term Change in Weight
Weight will be measured in kilograms using a stadiometer
Time frame: Baseline to 6 months post surgery
Energy Expenditure (EE)
24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique
Time frame: Baseline to 6 months
Change in Cholesterol
Cholesterol will be measured using a standard lipid panel.
Time frame: Baseline to 6 months post surgery
Change in Quality of Life
ThyPRO-39, a thyroid specific quality of life instrument, was used to assess a participant's quality of life. ThyPRO-39 interrogates 12 individual domains and a composite on the 0 to 100 scale (0 best). A difference of 5 points corresponds to a small to moderate effect between two treatment arms. This outcome represents the change in score between when taken at baseline and then again at 6 months post surgery. The larger the increase in score, the better the improvement in the participant's quality of life. Each domain and the composite are being reported separately.
Time frame: Baseline to 6 months post surgery
| Milestone | Single Therapy | Combination Therapy |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Weight will be measured in kilograms using a stadiometer
| Kilogram | Single Therapy | Combination Therapy |
|---|---|---|
| Short Term Change in Weight | 1.7 ± 3.9 | -0.76 ± 2.1 |
24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique
| calorie over 24 hours | Single Therapy | Combination Therapy |
|---|---|---|
| Energy Expenditure (EE) | -39 ± 68 | 25 ± 29 |
Cholesterol will be measured using a standard lipid panel.
| mg/dL | Single Therapy | Combination Therapy |
|---|---|---|
| Change in Cholesterol | 43 ± 73 | -35 ± 52 |
ThyPRO-39, a thyroid specific quality of life instrument, was used to assess a participant's quality of life. ThyPRO-39 interrogates 12 individual domains and a composite on the 0 to 100 scale (0 best). A difference of 5 points corresponds to a small to moderate effect between two treatment arms. This outcome represents the change in score between when taken at baseline and then again at 6 months post surgery. The larger the increase in score, the better the improvement in the participant's quality of life. Each domain and the composite are being reported separately.
| score on a scale | Single Therapy | Combination Therapy |
|---|---|---|
| Composite | 14.3 ± 28.3 | 45 ± 64.7 |
| Domain: Goiter | 23.8 ± 36.8 | 45 ± 38 |
| Domain: Hyperthyroid | 12.5 ± 20.4 | 15 ± 18.1 |
| Domain: Hypothyroid | -2.7 ± 17.2 | 10 ± 24 |
| Domain: Eye | 13.1 ± 17.3 | 5 ± 12.6 |
| Domain: Tiredness | 11.2 ± 19.3 | 36.7 ± 45.1 |
| Domain: Cognitive | 14.3 ± 15.8 | 33.3 ± 45.3 |
| Domain: Anxiety | 14.3 ± 19.1 | 41.7 ± 45.2 |
| Domain: Depressivity | 2.3 ± 11.5 | 30 ± 42.3 |
| Domain: Emotional | 9.5 ± 18.9 | 40 ± 41.8 |
| Domain: Social life | 9.5 ± 14 | 25 ± 34.4 |
| Domain: Daily life | 7.14 ± 13.1 | 38.3 ± 51.2 |
| Domain: Appearance | 9.5 ± 47.2 | 38.3 ± 62.8 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Therapy | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Combination Therapy | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | Single Therapy | Combination Therapy |
|---|---|---|
| Unexpected TSH SuppressionEndocrine disorders | 0/7 | 1/6 |
| Age, Categorical(Participants) | Single Therapy | Combination Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 6 | 13 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Single Therapy | Combination Therapy | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Single Therapy | Combination Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 6 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Single Therapy | Combination Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 6 | 3 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Single Therapy | Combination Therapy | Total |
|---|---|---|---|
| United States | 7 | 6 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2020 to primary completion in Apr 2023, 29 months.
Results were first posted in Jun 2024, 1 year 1 month after primary completion. A results delay was requested in Apr 2024.
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Studies of the drug tested here: Triiodothyronine
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