Correction of Selenium Deficiency Has Effect on Thyroid Function

Not Applicable

• Conditions: Selenium Deficiency
• Interventions: Dietary Supplement: selenium supplementation; Dietary Supplement: ordinary corn powder

• Registration Number: NCT03445078
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Study Start: 2018-09-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	selenium supplementation	Participants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period.
B	ordinary corn powder	Participants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period.
A	selenium supplementation	Participants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period.
A	ordinary corn powder	Participants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period.

Primary Outcome Measures

Name	Time	Method
comparison of thyroid function	plasma sample will be collected at -1w/4w/8w/12w	comparison of thyroid function between administration of selenium supplementation and placebo

Secondary Outcome Measures

Name	Time	Method
comparison of serum selenium	plasma sample will be collected at -1w/4w/8w/12w	comparison of serum selenium between administration of selenium supplementation and placebo
comparison of erythrocyte glutathione peroxidase activity	plasma sample will be collected at -1w/4w/8w/12w	comparison of erythrocyte glutathione peroxidase activity between administration of selenium supplementation and placebo
comparison of serum deiodinase activity	plasma sample will be collected at -1w/4w/8w/12w	comparison of serum deiodinase activity between administration of selenium supplementation and placebo