Correction of Selenium Deficiency Has Effect on Thyroid Function

NCT ID: NCT03445078

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-04-01

Brief Summary

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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

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Conditions

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Selenium Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

20 participants with selenium deficiency (confirmed in previous phase (ID: Liuyanping3)) will be recruited to receive selenium-rich corn powder (20g/d, offering selenium 100μg/d) and ordinary corn powder (20g/d, offering selenium \< 0.5μg/d ) in two different sequences (10 subjects each) with a four-week washout period.Plasma samples were obtained at different time points before and after administration of the selenium-rich corn powder and ordinary corn powder.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
All participants will be blinded. Both the selenium-rich corn powder and the ordinary corn powder (placebo) have the same smell, color and taste.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

selenium supplementation

Intervention Type DIETARY_SUPPLEMENT

administration of selenium-rich corn powder 20g/d offering selenium 100μg/d

ordinary corn powder

Intervention Type DIETARY_SUPPLEMENT

ordinary corn powder,20g/d(selenium contain \<0.5ug/20g).

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.

Group Type PLACEBO_COMPARATOR

selenium supplementation

Intervention Type DIETARY_SUPPLEMENT

administration of selenium-rich corn powder 20g/d offering selenium 100μg/d

ordinary corn powder

Intervention Type DIETARY_SUPPLEMENT

ordinary corn powder,20g/d(selenium contain \<0.5ug/20g).

Interventions

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selenium supplementation

administration of selenium-rich corn powder 20g/d offering selenium 100μg/d

Intervention Type DIETARY_SUPPLEMENT

ordinary corn powder

ordinary corn powder,20g/d(selenium contain \<0.5ug/20g).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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low selenium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liuyanping

nutrition physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yanping Liu

Role: CONTACT

Phone: +861069159088

Email: [email protected]

Other Identifiers

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Liuyanping4

Identifier Type: -

Identifier Source: org_study_id