Correction of Selenium Deficiency Has Effect on Thyroid Function

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Selenium Deficiency

Treatments: Dietary Supplement: ordinary corn powder; Dietary Supplement: selenium supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03445078

Liuyanping4

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: selenium supplementation

Dietary Supplement: ordinary corn powder

B

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: selenium supplementation

Dietary Supplement: ordinary corn powder