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Trial record 91 of 580 for:    reduced glutathione

Correction of Selenium Deficiency Has Effect on Thyroid Function

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ClinicalTrials.gov Identifier: NCT03445078
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Liuyanping, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Selenium Deficiency Dietary Supplement: selenium supplementation Dietary Supplement: ordinary corn powder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: All participants will be blinded. Both the selenium-rich corn powder and the ordinary corn powder (placebo) have the same smell, color and taste.
Primary Purpose: Diagnostic
Official Title: Correction of Selenium Deficiency Has Effect on Thyroid Function
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

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 Name: 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 Name: low selenium




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445078


Contacts
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Contact: Yanping Liu +861069159088 liuyp1227@vip.sina.com

Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Liuyanping, nutrition physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03445078     History of Changes
Other Study ID Numbers: Liuyanping4
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances