HypothyroidismPhase 4NCT01848171
Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
A Phase 4 study testing L-thyroxine in people with Hypothyroidism and Thyroid Diseases, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- What is being tested?
- L-thyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40~75 years old
- Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months
Who cannot join
- Pregnant or lactating women
- Severe hepatic or renal dysfunction
- Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism
- Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism
- Obviously poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.
Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.
- Conditions
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- Being tested
- L-thyroxine
- Keywords
- Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine, coronavirus disease 2019 (COVID-19)
- Medical subject headings
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases, Atherosclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-thyroxineDrug
Also called Euthyrox
| Study group | Role | What they receive |
|---|---|---|
| L-thyroxine | Active comparator | Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period Receives: Drug: L-thyroxine |
| blank | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
Measured: endpoint of the trail
Secondary outcomes (4)
Change in Serum Lipid Levels
Measured: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
Change in Thickness of Blood Vessel Wall
Measured: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis
Measured: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
Changes in Serum Metabolome and Lipidome
Measured: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
- Investigators
- Zhao jiajun, Study chair, Shandong Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848171
- Sponsor's protocol ID
- 20130328
- Status last verified
- May 2022
- First submitted
- 2 May 2013
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yao Z, Zhao M, Gong Y, Chen W, Wang Q, Fu Y, Guo T, Zhao J, Gao L, Bo T. Relation of Gut Microbes and L-Thyroxine Through Altered Thyroxine Metabolism in Subclinical Hypothyroidism Subjects. Front Cell Infect Microbiol. 2020 Sep 18;10:495. doi: 10.3389/fcimb.2020.00495. eCollection 2020.
PubMed 33072620Liu L, Yu Y, Zhao M, Zheng D, Zhang X, Guan Q, Xu C, Gao L, Zhao J, Zhang H. Benefits of Levothyroxine Replacement Therapy on Nonalcoholic Fatty Liver Disease in Subclinical Hypothyroidism Patients. Int J Endocrinol. 2017;2017:5753039. doi: 10.1155/2017/5753039. Epub 2017 Apr 4.
PubMed 28473851
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
- ClinicalTrials.gov ID
- NCT01848171
- Acronym / sponsor ID
- 20130328
- Conditions
- Hypothyroidism, Thyroid Diseases, Endocrine System Diseases
- Keywords
- Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Jul 2013
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.
Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-thyroxine | Active comparator | Drug: L-thyroxineOral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period |
| blank | No intervention | –No intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40~75 years old
- Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Severe hepatic or renal dysfunction
- Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism
- Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism
- Obviously poor compliance.
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 |
|---|---|---|
| L-thyroxineAlso: Euthyrox | Drug | L-thyroxine |
Primary outcome
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
Time frame: endpoint of the trail
4 secondary outcomes
Change in Serum Lipid Levels
Time frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
Change in Thickness of Blood Vessel Wall
Time frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis
Time frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
Changes in Serum Metabolome and Lipidome
Time frame: baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 33072620Yao Z, Zhao M, Gong Y, Chen W, Wang Q, Fu Y, Guo T, Zhao J, Gao L, Bo T. Relation of Gut Microbes and L-Thyroxine Through Altered Thyroxine Metabolism in Subclinical Hypothyroidism Subjects. Front Cell Infect Microbiol. 2020 Sep 18;10:495. doi: 10.3389/fcimb.2020.00495. eCollection 2020.
- Derived from this study: PubMed 28473851Liu L, Yu Y, Zhao M, Zheng D, Zhang X, Guan Q, Xu C, Gao L, Zhao J, Zhang H. Benefits of Levothyroxine Replacement Therapy on Nonalcoholic Fatty Liver Disease in Subclinical Hypothyroidism Patients. Int J Endocrinol. 2017;2017:5753039. doi: 10.1155/2017/5753039. Epub 2017 Apr 4.
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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.
Zhao jiajun study chair
Shandong Province Hospital
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 L-thyroxine in people with Hypothyroidism and Thyroid Diseases, run by Shandong Provincial Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 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 China. 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. 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?
Results are not available in the source record.
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?
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality (time frame: endpoint of the trail). 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 NCT01848171, which also lists 2 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 Jan 2023.