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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848171
Recruitment Status : Active, not recruiting
First Posted : May 7, 2013
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jia-jun Zhao, Shandong Provincial Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date March 18, 2020
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality [ Time Frame: endpoint of the trail ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
  • 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
Official Title  ICMJE Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypothyroidism
  • Thyroid Diseases
  • Endocrine System Diseases
Intervention  ICMJE Drug: L-thyroxine
Other Name: Euthyrox
Study Arms  ICMJE
  • Active Comparator: L-thyroxine
    Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
    Intervention: Drug: L-thyroxine
  • No Intervention: blank
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2013)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848171
Other Study ID Numbers  ICMJE 20130328
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jia-jun Zhao, Shandong Provincial Hospital
Study Sponsor  ICMJE Shandong Provincial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhao jiajun Shandong Province Hospital
PRS Account Shandong Provincial Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP