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

S

Shandong First Medical University

Status and phase

Unknown
Phase 4

Conditions

Thyroid Diseases
Hypothyroidism
Endocrine System Diseases

Treatments

Drug: L-thyroxine

Study type

Interventional

Funder types

Other

Identifiers

NCT01848171
20130328

Details and patient eligibility

About

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.

Enrollment

700 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

700 participants in 2 patient groups

L-thyroxine
Active Comparator group
Description:
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
Treatment:
Drug: L-thyroxine
blank
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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