Correction of Selenium Deficiency Has Effect on Thyroid Function

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.

Study Overview

• Status: Unknown
• Conditions: Selenium Deficiency
• Intervention / Treatment: Dietary supplement: selenium supplementation; Dietary supplement: ordinary corn powder

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A; 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.	Dietary supplement: selenium supplementation; administration of selenium-rich corn powder 20g/d offering selenium 100μg/d; Dietary supplement: ordinary corn powder; ordinary corn powder,20g/d(selenium contain <0.5ug/20g).; Other Names: low selenium
PLACEBO_COMPARATOR: B; 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.	Dietary supplement: selenium supplementation; administration of selenium-rich corn powder 20g/d offering selenium 100μg/d; Dietary supplement: ordinary corn powder; ordinary corn powder,20g/d(selenium contain <0.5ug/20g).; Other Names: low selenium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: Liuyanping4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No