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Trial registered on ANZCTR


Registration number
ACTRN12611000201976
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
21/02/2011
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Clinical Trial to test the effectiveness of Lactoferrin (a protein found naturally in milk) in reducing the incidence and/or duration of the common cold.
Scientific title
A prospective phase IIa randomised placebo controlled study to evaluate the safety and efficacy of a Lactoferrin/Immunoglobulin preparation to prevent the onset of a cold or reduce the time of symptoms in pateints with a cold.
Secondary ID [1] 259648 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The common cold 243611 0
Condition category
Condition code
Alternative and Complementary Medicine 239906 239906 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each gelatin capsules contains:
Milled Glycomax Lactoferrin 220mg
Glycomax Immunoglobulin 104mg
Magnesium stearate 5.4mg

Dosage: Oral ingestion of 2 capsules per day taken simulataneously in the morning for a total of 90 days.
Intervention code [1] 241198 0
Treatment: Other
Comparator / control treatment
Placebo capsule

Each Placebo gelatin capsule contains:
calcium hydrogen phosphate 300mg
magnesium stearate 5.4mg

Dosage: Oral ingestion of 2 capsules per day taken simulataneously in the morning for a total of 90 days

The calcium hydrogen phosphate will be acting as the placebo control compared to the Lactoferrin preparation.
Control group
Placebo

Outcomes
Primary outcome [1] 240689 0
A decrease in the number of cold events.

To assess a decrease in the number of cold events we enrol participants who self admit to suffering at least one cold event per month. At baseline, a case report which includes data collection and questionnaires will be completed. Over the 90 day trial, participants are required to record any cold or associated symptoms they may suffer, subsequent medications adminstered, record date and total intervention capsules taken each day in addition to any adverse events in a diary provided to them. Analysis of data at the end of the trial will compare cold events and severity recorded by those in the treatment group and those in the placebo group.
Timepoint [1] 240689 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).
Primary outcome [2] 240690 0
A decrease in time to symptom resolution in the event of a cold
Timepoint [2] 240690 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).
Primary outcome [3] 240691 0
A decrease in severity of cold symptoms.

To assess a decrease in the severity of cold events we enrol participants who self admit to suffering at least one cold event per month. At baseline, a case report which includes data collection and questionnaires will be completed. Over the 90 day trial, participants are required to record any cold or associated symptoms they may suffer, subsequent medications adminstered, record date and total intervention capsules taken each day in addition to any adverse events in a diary provided to them. Analysis of data at the end of the trial will compare cold events and severity recorded by those in the treatment group and those in the placebo group.
Timepoint [3] 240691 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).
Secondary outcome [1] 257328 0
Changes in Quality of life (QOL).

The outcomes for the changes in QOL will be assessed through three questionnaires:

* the SF-12 short questionnaire,
* the stress questionnaire
* a 3-day diet recall questionnaire.
Timepoint [1] 257328 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).
Secondary outcome [2] 257329 0
Changes in International physical acitivity questionnaire
Timepoint [2] 257329 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).
Secondary outcome [3] 257330 0
Changes in perceived stress scale
Timepoint [3] 257330 0
90 days.

The 90 day time point will occur 90 days from the baseline interview and randomisation process which will be the first day they start to take the capsules (active or placebo).

Eligibility
Key inclusion criteria
Self report of 1-2 colds per month.
Participants are classified as experiencing cold events frequently, self-limiting, non-chronic events but who are otherwise healthy, i.e. do not suffer from any serious health conditions such as cardiovascular disease, diabetes etc.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The use of vitamin/mineral supplements, probiotics, herbs and fish oils for the duration of the trial.
Femeals who are lactating, pregnant or planning to become pregnant.
History of alcohol or substance abuse.
History of serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, neurologic or neuropsychiatric disorders.

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)
Potential participants contact us in response to an advertisement, during which we assess their suitability. If suitable they are asked to attend the Princess Alexandra Hospital for their first visit.
Treatment is allocated according to their arrival.
Allocation concealment is performed by prepacked, numbered coded, opaque containers. As we see participants they are allocated the next available number on entry into the study which corresponds to a coded treatment. The randomisation of the numbers are computer-generated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is determined by a computer program. As each participant attends their first appointment they are allocated either A or B according to which letter is next on the list. A referring to product code LF20077 and B referring to LF20078.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237556 0
Commercial sector/Industry
Name [1] 237556 0
Probiotec Pharma
Country [1] 237556 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Probiotec Pharma
Address
83 Cherry lane
Laverton North
VIC 3026
Country
Australia
Secondary sponsor category [1] 237032 0
University
Name [1] 237032 0
University of Queensland
Address [1] 237032 0
Princess Alexandra Hospital
Centres for Health research
Level 2, R wing
Ipswich Rd
Woolloongabba
QLD 4102
Country [1] 237032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243689 0
University of Queensland
Ethics committee address [1] 243689 0
St Lucia
QLD 4072
Ethics committee country [1] 243689 0
Australia
Date submitted for ethics approval [1] 243689 0
15/10/2007
Approval date [1] 243689 0
15/11/2007
Ethics approval number [1] 243689 0
2007001017

Summary
Brief summary
Whey proteins are normally found in milk. Supplementation appears to strengthen the immune system by promoting anti-bacterial activity. Lactoferrin is a protein isolated from whey proteins in milk with documented anti-bacterial, anti-fungal, anti-viral, and immune function strengthening effects. Studies have shown lactoferrin is an iron-binding protein that is present in body secretions such as tears, nasal exudates, saliva, and bronchial mucus. A high concentration is also found in breast milk to help the infant fight infection. Lactoferrin is also a major component of circulating white blood cells known as neutrophils and is released by these cells in infected areas. Further, lactoferrin has also been shown in laboratory experiments to bind to viral receptor sites and inhibit the growth of several viruses that include HIV, Herpes simplex 1 and 2, hepatitis C, and human cytomegalovirus.
To date, there are no clinical trials that have specifically investigated the effect of lactoferrin to prevent or treat the common cold. However, because of its scientifically demonstrated antiviral, antibacterial, and anti-inflammatory properties, lactoferrin may be of benefit in alleviating the symptoms or complications of these viral infections and a clinical trial could introduce significant merit to clinical claims.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30100 0
Address 30100 0
Country 30100 0
Phone 30100 0
Fax 30100 0
Email 30100 0
Contact person for public queries
Name 13347 0
Samantha Coulson
Address 13347 0
Princess Alexandra Hospital
Centres for Health Research
level 2, R wing
Ipswich rd
Woolloongabba
QLD AUSTRALIA 4102
Country 13347 0
Australia
Phone 13347 0
+61 7 3176 5273
Fax 13347 0
Email 13347 0
[email protected]
Contact person for scientific queries
Name 4275 0
Samantha Coulson
Address 4275 0
Princess Alexandra Hospital
Centres for Health Research
level 2, R wing
Ipswich rd
Woolloongabba
QLD AUSTRALIA 4102
Country 4275 0
Australia
Phone 4275 0
+61 7 3240 5273
Fax 4275 0
Email 4275 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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