NCT04188483

Brief Summary

The study is designed to assess whether selenium supplementation can boost the immunity response to influenza vaccination in healthy adults. This is a randomized, prospective study enrolling a total of 60 healthy subjects, 18-55 years old.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

October 13, 2019

Last Update Submit

February 13, 2020

Conditions

Selenium SupplementationInfluenza Vaccination

Outcome Measures

Primary Outcomes (1)

  • The production of antigen-specific antibodies after vaccination

    Viral strain-specific antibodies in serum at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination) will be measured by hemagglutination inhibition (HAI) assay

    60 days

Secondary Outcomes (7)

  • Immune cell responses after selenium supplementation and vaccination

    60 days

  • Immune cytokine IFN-γ after selenium supplementation and vaccination

    60 days

  • Immune cytokine IL-4 after selenium supplementation and vaccination

    60 days

  • Immune cytokine IL-10 after selenium supplementation and vaccination

    60 days

  • Immune cytokine IL-17A after selenium supplementation and vaccination

    60 days

  • +2 more secondary outcomes

Study Arms (2)

Selenium Supplementation

EXPERIMENTAL

The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days. Thirty days after the start of the supplementation, the subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.

Dietary Supplement: Selenium SupplementationBiological: Influenza vaccination

Non-Selenium Supplementation

OTHER

The control group will not receive selenium supplementation. Thirty days after allocation, the subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.

Biological: Influenza vaccination

Interventions

Selenium SupplementationDIETARY_SUPPLEMENT

The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days.

Selenium Supplementation
Influenza vaccinationBIOLOGICAL

Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.

Non-Selenium SupplementationSelenium Supplementation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years, healthy subjects

You may not qualify if:

  • With the history of selenium supplementation as taking supplementation products or living more than 2 years in selenium-enriched area;
  • Had the symptoms of selenium toxicity or serum selenium level greater than 328 μg/L;
  • With the history of the administration of influenza vaccine in past three years or allergic to influenza vaccine;
  • With any current immunologic disorders, including autoimmune and allergic diseases;
  • With any cardiovascular, metabolic, mental, or psychological disorders;
  • Pregnancy or breastfeeding;
  • With the history of infectious diseases including airway infections in past three months;
  • Who are currently participating in other clinical studies or who have participated in other clinical research within 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Zheng Liu, Doctor

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otolaryngology-Head & Neck Surgery, Deputy Dean of The Second Clinical Medical School,Deputy Dean of Tongji Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Record Dates

First Submitted

October 13, 2019

First Posted

December 6, 2019

Study Start

October 15, 2019

Primary Completion

December 31, 2019

Study Completion

February 1, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CN(1)