Efficacy of Selenium Enriched Milk Study 2007

Phase 4

Completed

• Conditions: pper respiratory tract infections in healthy volunteers; Upper respiratory tract infections in healthy volunteers; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12607000251426
• Lead Sponsor: Commonwealth Scientific Industrial Research Organisation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Agree to informed consent

Exclusion Criteria

Does not agree with informed consent• Allergic/Intolerant to dairy products• Unable to receive influenza vaccine (for example, has an egg allergy)• Negative health event that occurs during the trial that makes it unreasonable for participants to continue (such as heart attack)• A bleeding disorder (such as Haemophilia), or taking medication (such as anti-coagulants) that may preclude venipuncture • Taking selenium supplements, or supplementing with vitamins/ anti-oxidants such as folate, vitamins B12, C and E at levels above RDI• Unable to comprehend/ comply with study protocol• Not available for all sampling phases of the experiment• Chronic degenerative diseases• Chronic colitis• Chronic airway disease• Diabetes• Cancer• Significant heart disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of a 112 day supplementation with Selenium (Se)-enriched milk on:<br>2) Immune responsiveness after exposure to influenza vaccine. Vaccine given at week 5.[2) Immune responsiveness after exposure to influenza vaccine where the vaccine is given at week 5, then blood sample at week 16 to assess immune function and selenium concentration.];To determine the effect of a 112 day supplementation with Selenium (Se)-enriched milk on:<br>1) The incidence, duration and severity of upper respiratory tract infections (URTI).<br>2) Immune responsiveness after exposure to influenza vaccine. Vaccine given at week 5.[1) The incidence, duration and severity of upper respiratory tract infections (URTI) is recorded in a symptoms diary every day of the study.<br>2) Immune responsiveness after exposure to influenza vaccine where the vaccine is given at week 5, then blood sample at week 16 to assess immune function and selenium concentration.]

Secondary Outcome Measures

Name	Time	Method
Plasma selenium concentration changes [At weeks 0, 5, 16 and 21.]