Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000251426
Ethics application status
Approved
Date submitted
4/05/2007
Date registered
10/05/2007
Date last updated
10/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Selenium Enriched Milk Study 2007
Scientific title
A 112 day parallel study investigating the effects of selenium enriched milk on the incidence, duration and severity of upper respiratory tract infections in healthy volunteers
Secondary ID [1] 363 0
Commonwealth Scientific Industrial Research Organisation: Ld29a
Universal Trial Number (UTN)
Trial acronym
SM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract infections in healthy volunteers 1790 0
Condition category
Condition code
Respiratory 1876 1876 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
112 day intervention of:
selenium enriched milk protein in volunteers who have already had the influenza vaccine and in volunteers who will be given the influenza vaccine.
Volunteers are required to consume 50gm of the randomly allocated milk protein once daily mixed with 200ml of tap water.
Intervention code [1] 1738 0
Prevention
Comparator / control treatment

Non selenium enriched milk protein (placebo).
Control group
Active

Outcomes
Primary outcome [1] 2664 0
To determine the effect of a 112 day supplementation with Selenium (Se)-enriched milk on:
1) The incidence, duration and severity of upper respiratory tract infections (URTI).
2) Immune responsiveness after exposure to influenza vaccine. Vaccine given at week 5.
Timepoint [1] 2664 0
1) The incidence, duration and severity of upper respiratory tract infections (URTI) is recorded in a symptoms diary every day of the study.
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.
Primary outcome [2] 2665 0
To determine the effect of a 112 day supplementation with Selenium (Se)-enriched milk on:
2) Immune responsiveness after exposure to influenza vaccine. Vaccine given at week 5.
Timepoint [2] 2665 0
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 [1] 4524 0
Plasma selenium concentration changes
Timepoint [1] 4524 0
At weeks 0, 5, 16 and 21.

Eligibility
Key inclusion criteria
Agree to informed consent
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed when it was done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2023 0
Government body
Name [1] 2023 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 2023 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
Country
Australia
Secondary sponsor category [1] 1833 0
None
Name [1] 1833 0
n/a
Address [1] 1833 0
Country [1] 1833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3753 0
CSIRO Human Nutrition
Ethics committee address [1] 3753 0
Ethics committee country [1] 3753 0
Australia
Date submitted for ethics approval [1] 3753 0
Approval date [1] 3753 0
10/10/2006
Ethics approval number [1] 3753 0
06/42

Summary
Brief summary
Parallel study of 150 healthy participants (male and female) 65 years of age or more who pass the inclusion criteria will be randomly assigned to 2 interventions.
• Approx. 75 people, to receive placebo (control) for a total of 112 days
• Approx. 75 people, isonitrogenous and isocaloric Se-enriched powdered milk supplement approx 120-150 ug Se/ day for a total of 112 days.
The non-vaccinated volunteers will be inoculated with influenza vaccine at a common time point between 28 and 42 days (4 and 6 weeks) after starting the supplement. Blood samples (20mL) will be collected during the experiment (days 0, one day between 28 and 42,112 and 150) to quantitate blood selenium, anti-oxidant status and immune function.
Compliance and upper respiratory tract infection data will be collected by the volunteer for the duration of the study. This data will be retrieved from the volunteer at the conclusion of the study.
From these measurements, it shall be determined whether increased immune function was achieved during nutritional supplementation with the Se-enriched milk supplement compared to control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27841 0
Address 27841 0
Country 27841 0
Phone 27841 0
Fax 27841 0
Email 27841 0
Contact person for public queries
Name 10927 0
Anne McGuffin
Address 10927 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10927 0
Australia
Phone 10927 0
+61 8 83038988
Fax 10927 0
+61 8 83038899
Email 10927 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 1855 0
Peter Royle
Address 1855 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1855 0
Australia
Phone 1855 0
+61 8 83038947
Fax 1855 0
+61 8 83038899
Email 1855 0
peter.royle@csiro.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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