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Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jia-jun Zhao, Shandong Provincial Hospital Identifier:
First received: May 2, 2013
Last updated: April 25, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Thyroid Diseases
Endocrine System Diseases
Drug: L-thyroxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism

Resource links provided by NLM:

Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Study Start Date: July 2013
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-thyroxine
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Drug: L-thyroxine
Other Name: Euthyrox
No Intervention: blank
No intervention


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT01848171

China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Study Chair: Zhao jiajun Shandong Province Hospital
  More Information

Responsible Party: Jia-jun Zhao, Professor, Shandong Provincial Hospital Identifier: NCT01848171     History of Changes
Other Study ID Numbers: 20130328
Study First Received: May 2, 2013
Last Updated: April 25, 2017

Keywords provided by Shandong Provincial Hospital:
Oxidative Stress
Chronic Inflammation
Endothelial Function

Additional relevant MeSH terms:
Endocrine System Diseases
Thyroid Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 24, 2017