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Research on Association Between Selenium Deficiencies and Change of Thyroid Function

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: NCT03448588
Recruitment Status : Unknown
Verified May 2018 by Liuyanping, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Liuyanping, Peking Union Medical College Hospital

Study Description
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Brief Summary:
As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Previous literature has disclosed effect of selenium deficiency on inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the association between selenium deficiency and abnormally elevated T4 or T4/T3, which may provide more clues for establishing effective selenium assesment methods.

Condition or disease Intervention/treatment
Selenium Deficiency Diagnostic Test: detection of serum selenium

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Effect of Selenium Deficiency on Thyroid Function
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 1, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
group with normal T4 level or T4/T3
participants with T4 within 4.3-12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) ≤7.52, which are considered to be normal T4 level and T4/T3.
 Diagnostic Test: detection of serum selenium
For this case-control study, no intervention will be administered to participants, only serum sample will be collected for selenium assessment
group with elevated T4 level or T4/T3
participants with T4 more than 12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) > 7.52, which are considered to be elevated T4 level and T4/T3.
 Diagnostic Test: detection of serum selenium
For this case-control study, no intervention will be administered to participants, only serum sample will be collected for selenium assessment


Outcome Measures
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Primary Outcome Measures :
  1. between-group difference in serum selenium [ Time Frame: up to 24 weeks ]
    comparison of the mean serum selenium between the two groups


Secondary Outcome Measures :
  1. between-group difference in serum deiodinase activity [ Time Frame: up to 24 weeks ]
    comparison of the mean deiodinase activity between the two groups

  2. between-group difference in erythrocyte glutathione peroxidase activity [ Time Frame: up to 24 weeks ]
    comparison of the mean erythrocyte glutathione peroxidase activity between the two groups


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be recruited from volunteers who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.
Criteria

Inclusion Criteria:

  • with normal free triiodothyronine( FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH).
  • without thyroid hormone replacement therapy
  • without medical history of thyroid surgery
  • without iodine radiotherapy;

Exclusion Criteria:

  • acute critical illness in the latest 1 year;
  • weight fluctuation by more than 5% in the latest 3 months;
  • eating disorders
  • neuropsychological disorders
  • allergy to corn or yeast
  • fail to give informed consents.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03448588


Contacts
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Contact: Yanping Liu +861069159088 liuyp1227@vip.sina.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: yanping liu, master    861069159081    liuyp1227@vip.sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Liuyanping, Dietitian, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03448588    
Other Study ID Numbers: Liuyanping3
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Trace Elements
Micronutrients