Selenium SupplementationNCT04188483
Effect of Selenium Supplementation on Influenza Vaccination
A study testing Selenium Supplementation and Influenza vaccination in people with Selenium Supplementation and Influenza Vaccination, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Selenium Supplementation, Influenza Vaccination
- What is being tested?
- Selenium Supplementation and Influenza vaccination
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years, healthy subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination
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.
Read the detailed description
Background: Selenium is an essential trace element required for human health and wellbeing. Despite mouse studies and human clinical trial suggest selenium supplementation might enhance immunity, little is known for the effects of selenium supplementation on humoral immunity. Vaccination is the most effective medical intervention to prevent infections and to reduce disability and mortality associated with infectious disease. However, some individuals, in healthy or disease conditions, mount less effective humoral immune responses to vaccination. Therefore, new strategy to enhance humoral immunity upon vaccination is highly sought after. Using mouse models, we have observed that selenium supplementation significantly increased antigen-specific antibody responses. Thus, we hypothesize that selenium supplementation may be beneficial in enhancing humoral immunity in humans.
Objectives: To investigate whether selenium supplementation will boost the humoral response to influenza vaccination in healthy adults.
Design and trial size: This is a randomized prospective study. A total of 60 healthy subjects, 18-55 years old, will be enrolled in this study.
Intervention and duration: The enrolled subjects will be randomized into selenium supplementation and control group. 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. The control group will not receive selenium supplementation. Thirty days after allocation, both groups will receive standard seasonal influenza vaccination for the 2019-2020 season. Peripheral blood samples will be collected at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination).
- Conditions
- Selenium Supplementation, Influenza Vaccination
- Being tested
- Selenium Supplementation, Influenza vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Influenza vaccinationBiological
Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Selenium Supplementation; Biological: 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. Receives: Biological: Influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Secondary outcomes (7)
Immune cell responses after selenium supplementation and vaccination
Frequencies (%) of immune cells including T cells, B cells, monocytes, dendritic cells, NK cells in peripheral blood 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 flow cytometry.
Measured: 60 days
Immune cytokine IFN-γ after selenium supplementation and vaccination
Levels of IFN-γ in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Measured: 60 days
Immune cytokine IL-4 after selenium supplementation and vaccination
Levels of IL-4 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Measured: 60 days
Immune cytokine IL-10 after selenium supplementation and vaccination
Levels of IL-10 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Measured: 60 days
Immune cytokine IL-17A after selenium supplementation and vaccination
Levels of IL-17A in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Measured: 60 days
Immune cytokine IL-21 after selenium supplementation and vaccination
Levels of IL-21 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Measured: 60 days
Selenium levels after selenium supplementation and vaccination
Level of selenium in plasma 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 inductively coupled plasma mass spectrometry (ICP-MS).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start15 Oct 2019
- Primary completion31 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selenium SupplementationStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Principal investigator, Zheng Liu, Huazhong University of Science and Technology
- Investigators
- Zheng Liu, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188483
- Sponsor's protocol ID
- ENT-SELENIUM-01
- Status last verified
- Feb 2020
- First submitted
- 13 Oct 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination
- ClinicalTrials.gov ID
- NCT04188483
- Acronym / sponsor ID
- ENT-SELENIUM-01
- Conditions
- Selenium Supplementation, Influenza Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Selenium is an essential trace element required for human health and wellbeing. Despite mouse studies and human clinical trial suggest selenium supplementation might enhance immunity, little is known for the effects of selenium supplementation on humoral immunity. Vaccination is the most effective medical intervention to prevent infections and to reduce disability and mortality associated with infectious disease. However, some individuals, in healthy or disease conditions, mount less effective humoral immune responses to vaccination. Therefore, new strategy to enhance humoral immunity upon vaccination is highly sought after. Using mouse models, we have observed that selenium supplementation significantly increased antigen-specific antibody responses. Thus, we hypothesize that selenium supplementation may be beneficial in enhancing humoral immunity in humans.
Objectives: To investigate whether selenium supplementation will boost the humoral response to influenza vaccination in healthy adults.
Design and trial size: This is a randomized prospective study. A total of 60 healthy subjects, 18-55 years old, will be enrolled in this study.
Intervention and duration: The enrolled subjects will be randomized into selenium supplementation and control group. 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. The control group will not receive selenium supplementation. Thirty days after allocation, both groups will receive standard seasonal influenza vaccination for the 2019-2020 season. Peripheral blood samples will be collected at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selenium Supplementation | Experimental | Dietary Supplement: Selenium Supplementation, Biological: Influenza vaccinationThe 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. |
| Non-Selenium Supplementation | Other | Biological: Influenza vaccinationThe control group will not receive selenium supplementation. Thirty days after allocation, the subjects will receive standard seasonal influenza vaccination for the 2019-2020 season. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-55 years, healthy subjects
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium SupplementationThe selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days. | Dietary supplement | Selenium Supplementation |
| Influenza vaccinationSubjects will receive standard seasonal influenza vaccination for the 2019-2020 season. | Biological | Non-Selenium Supplementation, Selenium Supplementation |
Primary outcome
The production of antigen-specific antibodies after vaccination
Time frame: 60 days
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
7 secondary outcomes
Immune cell responses after selenium supplementation and vaccination
Time frame: 60 days
Immune cytokine IFN-γ after selenium supplementation and vaccination
Time frame: 60 days
Immune cytokine IL-4 after selenium supplementation and vaccination
Time frame: 60 days
Immune cytokine IL-10 after selenium supplementation and vaccination
Time frame: 60 days
Immune cytokine IL-17A after selenium supplementation and vaccination
Time frame: 60 days
Immune cytokine IL-21 after selenium supplementation and vaccination
Time frame: 60 days
Selenium levels after selenium supplementation and vaccination
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Liu, Doctor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium Supplementation and Influenza vaccination in people with Selenium Supplementation and Influenza Vaccination, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The production of antigen-specific antibodies after vaccination (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.