Research on Association Between Selenium Deficiencies and Change of Thyroid Function

Effect of Selenium Deficiency on Thyroid Function

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.

Study Overview

• Status: Unknown
• Conditions: Selenium Deficiency
• Intervention / Treatment: Diagnostic test: detection of serum selenium

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: yanping liu, master; Phone Number: 861069159081; Email: liuyp1227@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
between-group difference in serum selenium	comparison of the mean serum selenium between the two groups	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
between-group difference in serum deiodinase activity	comparison of the mean deiodinase activity between the two groups	up to 24 weeks
between-group difference in erythrocyte glutathione peroxidase activity	comparison of the mean erythrocyte glutathione peroxidase activity between the two groups	up to 24 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: Liuyanping3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No