Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
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ClinicalTrials.gov Identifier: NCT01848171 |
Recruitment Status :
Active, not recruiting
First Posted : May 7, 2013
Last Update Posted : March 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypothyroidism Thyroid Diseases Endocrine System Diseases | Drug: L-thyroxine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: L-thyroxine
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
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Drug: L-thyroxine
Other Name: Euthyrox |
No Intervention: blank
No intervention
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- Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ]
- 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 ]

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 40~75 years old
- Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848171
China, Shandong | |
Shandong Provincial Hospital | |
Jinan, Shandong, China, 250021 |
Study Chair: | Zhao jiajun | Shandong Province Hospital |
Responsible Party: | Jia-jun Zhao, Professor, Shandong Provincial Hospital |
ClinicalTrials.gov Identifier: | NCT01848171 |
Other Study ID Numbers: |
20130328 |
First Posted: | May 7, 2013 Key Record Dates |
Last Update Posted: | March 18, 2020 |
Last Verified: | March 2020 |
Hypothyroidism Lipid Atherosclerosis Oxidative Stress |
Chronic Inflammation Endothelial Function Adipocytokine L-thyroxine |
Atherosclerosis Hypothyroidism Thyroid Diseases Endocrine System Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |