Correction of Selenium Deficiency Has Effect on Thyroid Function

Selenium Deficiency Clinical Trial

Official title:

Correction of Selenium Deficiency Has Effect on Thyroid Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03445078
• Other study ID #: Liuyanping4
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 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: Interventional

Clinical Trial Summary

Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study

• Should have stable body weight in the latest 3 months;

• Should be not prescribed with thyroid hormone replacement therapy

• Should be without medical history of thyroid surgery or iodine radiotherapy

• Should have normal FT3, FT4 and TSH.

Exclusion Criteria:

• Clinical diagnosis of acute critical illness in the latest 1 year

• Have had weight fluctuation by more than 5%

• Eating disorders

• Neuropsychological disorders

• Allergy to corn or yeast

Related Conditions & MeSH terms

• Selenium Deficiency

Intervention

Dietary Supplement:
• selenium supplementation
administration of selenium-rich corn powder 20g/d offering selenium 100µg/d
• ordinary corn powder
ordinary corn powder,20g/d(selenium contain <0.5ug/20g).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of thyroid function	comparison of thyroid function between administration of selenium supplementation and placebo	plasma sample will be collected at -1w/4w/8w/12w
Secondary	comparison of serum selenium	comparison of serum selenium between administration of selenium supplementation and placebo	plasma sample will be collected at -1w/4w/8w/12w
Secondary	comparison of erythrocyte glutathione peroxidase activity	comparison of erythrocyte glutathione peroxidase activity between administration of selenium supplementation and placebo	plasma sample will be collected at -1w/4w/8w/12w
Secondary	comparison of serum deiodinase activity	comparison of serum deiodinase activity between administration of selenium supplementation and placebo	plasma sample will be collected at -1w/4w/8w/12w