Research on Association Between Selenium Deficiencies and Change of Thyroid Function

• Conditions: Selenium Deficiency
• Interventions: Diagnostic Test: detection of serum selenium

• Registration Number: NCT03448588
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-02-28
• Study Start: 2018-04-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group with normal T4 level or T4/T3	detection of serum selenium	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.
group with elevated T4 level or T4/T3	detection of serum selenium	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.

Primary Outcome Measures

Name	Time	Method
between-group difference in serum selenium	up to 24 weeks	comparison of the mean serum selenium between the two groups

Secondary Outcome Measures

Name	Time	Method
between-group difference in serum deiodinase activity	up to 24 weeks	comparison of the mean deiodinase activity between the two groups
between-group difference in erythrocyte glutathione peroxidase activity	up to 24 weeks	comparison of the mean erythrocyte glutathione peroxidase activity between the two groups

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China