Research on Association Between Selenium Deficiencies and Change of Thyroid Function

Selenium Deficiency Clinical Trial

Official title:

Effect of Selenium Deficiency on Thyroid Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448588
• Other study ID #: Liuyanping3
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2018
• Source: Peking Union Medical College Hospital
• Contact: Yanping Liu
• Phone: +861069159088
• Email: liuyp1227[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Selenium Deficiency

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	between-group difference in serum selenium	comparison of the mean serum selenium between the two groups	up to 24 weeks
Secondary	between-group difference in serum deiodinase activity	comparison of the mean deiodinase activity between the two groups	up to 24 weeks
Secondary	between-group difference in erythrocyte glutathione peroxidase activity	comparison of the mean erythrocyte glutathione peroxidase activity between the two groups	up to 24 weeks