Subclinical HypothyroidismPhase 4NCT04288115
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
A Phase 4 study testing Levothyroxine in people with Subclinical Hypothyroidism, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- Levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans
- diagnosis of SCH
Who cannot join
- thyroid-stimulating hormone (TSH) > 10 milli-international units per liter (mlU/L) (at any point)
- Levothyroxine (LT4) dose more than 75 mcg daily
- use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium
- history of thyroidectomy or radioactive iodine therapy
- LT4 suppressive therapy for thyroid cancer, goiter, or inflammation
- pregnancy or plans for pregnancy in the next 6 months
Show all 19Show fewer
- an unstable medical condition that would jeopardize safety or interfere with study participation
- severe hypothyroidism-related symptoms
- strong family history of hypothyroidism
- severe dyslipidemia
- hospitalization for major illness within the previous 4 weeks
- acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12 months
- grade IV New York Heart Association heart failure
- receiving services from hospice
- lack of decision-making capacity
- terminal medical condition for which life expectancy would be less than 6 months
- not willing to stop LT4
- self-reported non-adherence to LT4 therapy
- abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
About this study
Official title: Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism: a Pilot Randomized, Double-blinded, Placebo-controlled Study
The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.
Read the detailed description
This is a pilot, randomized, double-blind, placebo-controlled trial.
Methodology:
The investigators will conduct a double-blind, placebo-controlled clinical trial where eligible veterans diagnosed with SCH and on LT4 will be 1:1 randomized to either continue LT4 or change to placebo. The primary outcome is intervention feasibility (willingness to enter the trial, recruitment rate, and completion rate). Secondary outcomes are: 1) changes in QoL measures (Hypothyroid Symptom [HSS] and Tiredness scale scores of the Thyroid-Specific Patient-Related Outcome Measure [ThyPRO], EuroQoL 5-Dimension Self-Report Questionnaire) measured at baseline, 6-8 weeks and 6 months and 2) changes in lipids assessed at baseline and 6 months, and 3) incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, fractures, acute myocardial infarction, stroke, acute coronary syndrome, heart failure, mortality).
- Conditions
- Subclinical Hypothyroidism
- Being tested
- Levothyroxine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid
Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
PlaceboOther
Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine group ("sham discontinuation") | Active comparator | Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc). Receives: Drug: Levothyroxine |
| Placebo group ("real discontinuation") | Placebo comparator | Stop the current dose of levothyroxine and take study placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Willingness to Enter the Trial
Percent of eligible participants approached who consented to participate during the recruitment phase.
Measured: The time from first consent signed to last consent signed. March 2021 to April 2022.
Recruitment Rate
The number of enrolled (consented) participants divided by the length of the recruitment period.
Measured: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.
Completion Rate
Percentage of randomized participants who completed the trial.
Measured: 6 months
Secondary outcomes (4)
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
The Hypothyroid Symptoms score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more symptoms.
Measured: Baseline, 6 weeks and 6 months
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score
The Tiredness score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more tiredness.
Measured: Baseline, 6 weeks and 6 months
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
The EuroQoL [EQ] Group 5-Dimension Self-Report Questionnaire (EQ-5D) scores include the EQ-5D descriptive index, on a scale from -0.59 to 1.00. Higher scores indicate better quality of life. The EQ-5D scores include the score on the EQ visual-analogue scale (EQ-5D VAS), on a scale from 0 to 100. Higher scores indicate better quality of life.
Measured: 6 weeks and 6 months
Lipid Levels
Differences in mean 6-month lipid levels after adjusting for gender and baseline lipid level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start24 Mar 2021
- Primary completion7 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Spyridoula Maraka, MD MS, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288115
- Sponsor's protocol ID
- PPO 20-056
- Other IDs
- 1521422
- Status last verified
- Nov 2023
- First submitted
- 14 Feb 2020
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brito JP, Ross JS, El Kawkgi OM, Maraka S, Deng Y, Shah ND, Lipska KJ. Levothyroxine Use in the United States, 2008-2018. JAMA Intern Med. 2021 Oct 1;181(10):1402-1405. doi: 10.1001/jamainternmed.2021.2686.
PubMed 34152370Feller M, Snel M, Moutzouri E, Bauer DC, de Montmollin M, Aujesky D, Ford I, Gussekloo J, Kearney PM, Mooijaart S, Quinn T, Stott D, Westendorp R, Rodondi N, Dekkers OM. Association of Thyroid Hormone Therapy With Quality of Life and Thyroid-Related Symptoms in Patients With Subclinical Hypothyroidism: A Systematic Review and Meta-analysis. JAMA. 2018 Oct 2;320(13):1349-1359. doi: 10.1001/jama.2018.13770.
PubMed 30285179Stott DJ, Rodondi N, Kearney PM, Ford I, Westendorp RGJ, Mooijaart SP, Sattar N, Aubert CE, Aujesky D, Bauer DC, Baumgartner C, Blum MR, Browne JP, Byrne S, Collet TH, Dekkers OM, den Elzen WPJ, Du Puy RS, Ellis G, Feller M, Floriani C, Hendry K, Hurley C, Jukema JW, Kean S, Kelly M, Krebs D, Langhorne P, McCarthy G, McCarthy V, McConnachie A, McDade M, Messow M, O'Flynn A, O'Riordan D, Poortvliet RKE, Quinn TJ, Russell A, Sinnott C, Smit JWA, Van Dorland HA, Walsh KA, Walsh EK, Watt T, Wilson R, Gussekloo J; TRUST Study Group. Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism. N Engl J Med. 2017 Jun 29;376(26):2534-2544. doi: 10.1056/NEJMoa1603825. Epub 2017 Apr 3.
PubMed 28402245Bekkering GE, Agoritsas T, Lytvyn L, Heen AF, Feller M, Moutzouri E, Abdulazeem H, Aertgeerts B, Beecher D, Brito JP, Farhoumand PD, Singh Ospina N, Rodondi N, van Driel M, Wallace E, Snel M, Okwen PM, Siemieniuk R, Vandvik PO, Kuijpers T, Vermandere M. Thyroid hormones treatment for subclinical hypothyroidism: a clinical practice guideline. BMJ. 2019 May 14;365:l2006. doi: 10.1136/bmj.l2006.
PubMed 31088853Ayala IN, Soto Jacome C, Toro-Tobon D, Golembiewski E, Garcia-Bautista A, Hidalgo J, Cordova-Madera S, Al Anbari R, Sohn R J, Singh Ospina N, Maraka S, Joseph M, Brito JP. Appropriateness of Levothyroxine Prescription: A Multicenter Retrospective Study. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e765-e772. doi: 10.1210/clinem/dgad517.
PubMed 37656124Toloza FJK, El Kawkgi OM, Spencer HJ, Mathews SE, Garcia A, Gamboa A, Mirza N, Mohan S, Vallejo S, Bogojevic M, Rodriguez-Gutierrez R, Singh Ospina NM, Brito JP, Maraka S. Determinants for Thyroid Hormone Replacement Therapy in Subclinical Hypothyroidism: A Multicenter Electronic Health Records-Based Study. Thyroid. 2023 Sep;33(9):1045-1054. doi: 10.1089/thy.2023.0062. Epub 2023 Jun 26.
PubMed 37279296Ospina NS, Salloum RG, Maraka S, Brito JP. De-implementing low-value care in endocrinology. Endocrine. 2021 Aug;73(2):292-300. doi: 10.1007/s12020-021-02732-y. Epub 2021 May 11.
PubMed 33977312Burgos N, Toloza FJK, Singh Ospina NM, Brito JP, Salloum RG, Hassett LC, Maraka S. Clinical Outcomes After Discontinuation of Thyroid Hormone Replacement: A Systematic Review and Meta-Analysis. Thyroid. 2021 May;31(5):740-751. doi: 10.1089/thy.2020.0679. Epub 2020 Dec 29.
PubMed 33161885Maraka S, Owen RR, Singh Ospina NM, Knox M, Dodds T, Thostenson JD, Dishongh K, Raciborski RA, Albashaireh A, Shah A, Syed S, Naqvi S, Motahari H, Thumma S, Toloza F, Ambrogini E, Brito JP. Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial. Endocrine. 2025 Nov;90(2):781-792. doi: 10.1007/s12020-025-04371-z. Epub 2025 Jul 30.
PubMed 40736623
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism: a Pilot Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04288115
- Acronym / sponsor ID
- PPO 20-056
- Conditions
- Subclinical Hypothyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.
Detailed description
This is a pilot, randomized, double-blind, placebo-controlled trial.
Methodology:
The investigators will conduct a double-blind, placebo-controlled clinical trial where eligible veterans diagnosed with SCH and on LT4 will be 1:1 randomized to either continue LT4 or change to placebo. The primary outcome is intervention feasibility (willingness to enter the trial, recruitment rate, and completion rate). Secondary outcomes are: 1) changes in QoL measures (Hypothyroid Symptom [HSS] and Tiredness scale scores of the Thyroid-Specific Patient-Related Outcome Measure [ThyPRO], EuroQoL 5-Dimension Self-Report Questionnaire) measured at baseline, 6-8 weeks and 6 months and 2) changes in lipids assessed at baseline and 6 months, and 3) incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, fractures, acute myocardial infarction, stroke, acute coronary syndrome, heart failure, mortality).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine group ("sham discontinuation") | Active comparator | Drug: LevothyroxineContinue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc). |
| Placebo group ("real discontinuation") | Placebo comparator | Other: PlaceboStop the current dose of levothyroxine and take study placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans
- diagnosis of SCH
Key exclusion criteria (19 listed)
- thyroid-stimulating hormone (TSH) > 10 milli-international units per liter (mlU/L) (at any point)
- Levothyroxine (LT4) dose more than 75 mcg daily
- use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium
- history of thyroidectomy or radioactive iodine therapy
- LT4 suppressive therapy for thyroid cancer, goiter, or inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineAlso: SynthroidParticipants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day. | Drug | Levothyroxine group ("sham discontinuation") |
| PlaceboParticipants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day. | Other | Placebo group ("real discontinuation") |
Primary outcome
Participants' Willingness to Enter the Trial
Time frame: The time from first consent signed to last consent signed. March 2021 to April 2022.
Percent of eligible participants approached who consented to participate during the recruitment phase.
Recruitment Rate
Time frame: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.
The number of enrolled (consented) participants divided by the length of the recruitment period.
Completion Rate
Time frame: 6 months
Percentage of randomized participants who completed the trial.
4 secondary outcomes
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
Time frame: Baseline, 6 weeks and 6 months
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score
Time frame: Baseline, 6 weeks and 6 months
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
Time frame: 6 weeks and 6 months
Lipid Levels
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34152370Brito JP, Ross JS, El Kawkgi OM, Maraka S, Deng Y, Shah ND, Lipska KJ. Levothyroxine Use in the United States, 2008-2018. JAMA Intern Med. 2021 Oct 1;181(10):1402-1405. doi: 10.1001/jamainternmed.2021.2686.
- Background: PubMed 30285179Feller M, Snel M, Moutzouri E, Bauer DC, de Montmollin M, Aujesky D, Ford I, Gussekloo J, Kearney PM, Mooijaart S, Quinn T, Stott D, Westendorp R, Rodondi N, Dekkers OM. Association of Thyroid Hormone Therapy With Quality of Life and Thyroid-Related Symptoms in Patients With Subclinical Hypothyroidism: A Systematic Review and Meta-analysis. JAMA. 2018 Oct 2;320(13):1349-1359. doi: 10.1001/jama.2018.13770.
- Background: PubMed 28402245Stott DJ, Rodondi N, Kearney PM, Ford I, Westendorp RGJ, Mooijaart SP, Sattar N, Aubert CE, Aujesky D, Bauer DC, Baumgartner C, Blum MR, Browne JP, Byrne S, Collet TH, Dekkers OM, den Elzen WPJ, Du Puy RS, Ellis G, Feller M, Floriani C, Hendry K, Hurley C, Jukema JW, Kean S, Kelly M, Krebs D, Langhorne P, McCarthy G, McCarthy V, McConnachie A, McDade M, Messow M, O'Flynn A, O'Riordan D, Poortvliet RKE, Quinn TJ, Russell A, Sinnott C, Smit JWA, Van Dorland HA, Walsh KA, Walsh EK, Watt T, Wilson R, Gussekloo J; TRUST Study Group. Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism. N Engl J Med. 2017 Jun 29;376(26):2534-2544. doi: 10.1056/NEJMoa1603825. Epub 2017 Apr 3.
- Background: PubMed 31088853Bekkering GE, Agoritsas T, Lytvyn L, Heen AF, Feller M, Moutzouri E, Abdulazeem H, Aertgeerts B, Beecher D, Brito JP, Farhoumand PD, Singh Ospina N, Rodondi N, van Driel M, Wallace E, Snel M, Okwen PM, Siemieniuk R, Vandvik PO, Kuijpers T, Vermandere M. Thyroid hormones treatment for subclinical hypothyroidism: a clinical practice guideline. BMJ. 2019 May 14;365:l2006. doi: 10.1136/bmj.l2006.
- Background: PubMed 37656124Ayala IN, Soto Jacome C, Toro-Tobon D, Golembiewski E, Garcia-Bautista A, Hidalgo J, Cordova-Madera S, Al Anbari R, Sohn R J, Singh Ospina N, Maraka S, Joseph M, Brito JP. Appropriateness of Levothyroxine Prescription: A Multicenter Retrospective Study. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e765-e772. doi: 10.1210/clinem/dgad517.
- Background: PubMed 37279296Toloza FJK, El Kawkgi OM, Spencer HJ, Mathews SE, Garcia A, Gamboa A, Mirza N, Mohan S, Vallejo S, Bogojevic M, Rodriguez-Gutierrez R, Singh Ospina NM, Brito JP, Maraka S. Determinants for Thyroid Hormone Replacement Therapy in Subclinical Hypothyroidism: A Multicenter Electronic Health Records-Based Study. Thyroid. 2023 Sep;33(9):1045-1054. doi: 10.1089/thy.2023.0062. Epub 2023 Jun 26.
- Background: PubMed 33977312Ospina NS, Salloum RG, Maraka S, Brito JP. De-implementing low-value care in endocrinology. Endocrine. 2021 Aug;73(2):292-300. doi: 10.1007/s12020-021-02732-y. Epub 2021 May 11.
- Background: PubMed 33161885Burgos N, Toloza FJK, Singh Ospina NM, Brito JP, Salloum RG, Hassett LC, Maraka S. Clinical Outcomes After Discontinuation of Thyroid Hormone Replacement: A Systematic Review and Meta-Analysis. Thyroid. 2021 May;31(5):740-751. doi: 10.1089/thy.2020.0679. Epub 2020 Dec 29.
- Derived from this study: PubMed 40736623Maraka S, Owen RR, Singh Ospina NM, Knox M, Dodds T, Thostenson JD, Dishongh K, Raciborski RA, Albashaireh A, Shah A, Syed S, Naqvi S, Motahari H, Thumma S, Toloza F, Ambrogini E, Brito JP. Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial. Endocrine. 2025 Nov;90(2):781-792. doi: 10.1007/s12020-025-04371-z. Epub 2025 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Subclinical Hypothyroidism
Not yet recruitingObservational study
Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Fatty Liver Disease
Not yet recruitingObservational study
Subclinical Hypothyroidism and Disease Activity in Rheumatoid Arthritis
Rheumatoid Arthritis, Subclinical Hypothyroidism
Not yet recruitingObservational study
Hypothyroidism and Liver Fibrosis Severity in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Hypothyroidism
Not yet recruitingPhase 4
Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism
Hypothyroidism
Recruiting
Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Levothyroxine, Cardiac Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spyridoula Maraka, MD MS principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine in people with Subclinical Hypothyroidism, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' Willingness to Enter the Trial (time frame: The time from first consent signed to last consent signed. March 2021 to April 2022.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288115, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.