Correction of Selenium Deficiency Has Effect on Thyroid Function

NCT03445078 | Unknown

• 1 other identifier: Liuyanping4
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Selenium Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• comparison of serum selenium

  plasma sample will be collected at -1w/4w/8w/12w

• comparison of erythrocyte glutathione peroxidase activity

  plasma sample will be collected at -1w/4w/8w/12w

• comparison of serum deiodinase activity

  plasma sample will be collected at -1w/4w/8w/12w

Study Arms (2)

A

ACTIVE COMPARATOR

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; Dietary Supplement: ordinary corn powder

B

PLACEBO COMPARATOR

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; Dietary Supplement: ordinary corn powder

Interventions

selenium supplementation DIETARY_SUPPLEMENT

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

A; B

ordinary corn powder DIETARY_SUPPLEMENT

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

Also known as: low selenium

A; B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Central Study Contacts

Yanping Liu

CONTACT

+861069159088; liuyp1227@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be blinded. Both the selenium-rich corn powder and the ordinary corn powder (placebo) have the same smell, color and taste.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nutrition physician

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 26, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 31, 2018

Record last verified: 2018-05