Research on Association Between Selenium Deficiencies and Change of Thyroid Function

NCT03448588 | Unknown

• 1 other identifier: Liuyanping3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Selenium Deficiency

Outcome Measures

Primary Outcomes (1)

• between-group difference in serum selenium

  comparison of the mean serum selenium between the two groups

  up to 24 weeks

Secondary Outcomes (2)

• between-group difference in serum deiodinase activity

  up to 24 weeks

• between-group difference in erythrocyte glutathione peroxidase activity

  up to 24 weeks

Study Arms (2)

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

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

Interventions

detection of serum selenium DIAGNOSTIC_TEST

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; group with normal T4 level or T4/T3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Central Study Contacts

Yanping Liu

CONTACT

+861069159088; liuyp1227@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: April 1, 2019
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)