Correction of Selenium Deficiency Has Effect on Thyroid Function

May 29, 2018 updated by: Liuyanping, Peking Union Medical College Hospital
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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