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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-thyroxine | Active Comparator | Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period |
|
| blank | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-thyroxine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality | endpoint of the trail |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Lipid Levels | 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 | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of COVID-19, COVID-19 Mortality, COVID-19 Related Complications and Severity of COVID-19 | Since January, 2023, every 6 months during the following follow-up period until the trail is completed |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao jiajun | Shandong Province Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33072620 | Derived | 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. | |
| 28473851 | Derived |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis | 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 | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed |
| Liu 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. |
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |