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Trial registered on ANZCTR
Registration number
ACTRN12625000674437p
Ethics application status
Submitted, not yet approved
Date submitted
27/05/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
MIC - Menaquinone in Children, checking Vitamin K2-Mk7 supplementation absorption and health effects in healthy children and adolescents.
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Scientific title
MIC - Menaquinone in Children, assessing the bioavailability of Mk-7 liquid supplement drops, and Vitamin K status changes in a double blind randomised control trial for 1 month of Vitamin K2-Mk7 versus placebo in fifty health children and adolescents aged 4 to 17 years old in Western Australia.
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Secondary ID [1]
314493
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G1006997
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Universal Trial Number (UTN)
U1111-1323-0238
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Trial acronym
MIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vitamin K2-Mk7 intestinal absorption
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Vitamin K Status
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Dietary Vitamin K intake
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Normal Dietary Intake - all macro and micronutrients
337550
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Anthropometry
337551
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Immune health
337552
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Intestinal Permeability
337554
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Faecal Microbiome
337555
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Vitamin K related genes
337557
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Internal carotenoid status
337558
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Condition category
Condition code
Diet and Nutrition
333904
333904
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0
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Other diet and nutrition disorders
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Oral and Gastrointestinal
333905
333905
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0
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Normal oral and gastrointestinal development and function
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Public Health
333906
333906
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0
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Other public health
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Inflammatory and Immune System
333907
333907
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0
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Normal development and function of the immune system
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Human Genetics and Inherited Disorders
333908
333908
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention is for 1 month taking daily liquid drops orally of Vitamin K2-Mk7 1.5 micrograms per kilogram of body weight in a home setting.
At baseline completing an online food frequency questionnaire.
At baseline and 1month- end of study,
- providing two non-consecutive days 24 hour dietary intake information
- collecting a faecal sample at home in an all in one kit
- having a blood sample taken by a paediatric experienced phlebotomist for serum Mk7 and three functional Vitamin K status markers, being protein induced in Vitamin K absence/deficiency (PIVKA-II), undercarboxylated osteocalcin (ucOC)/Osteocalcin (OC)/ ratio (UCR), and undercarboxylated Matrix-Gla protein (uc-MGP)
- having a finger reflection spectroscopy reading using a portable Veggie Meter Registered Trademark as RS units
- having an anthropometry (weight using scales, height using stadiometer, body composition analysis using a portable stand on Bioelectrical Impedance Analysis machine, waist circumference using a tape measure and hand grip strength using a dynamometer) assessment done
Compliance assessment - daily intake record and volume remaining on return of supplement at end of study visit.
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Intervention code [1]
331122
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Treatment: Other
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Comparator / control treatment
Control exposure is for 1 month taking daily liquid drops orally of oil - Medium Chain Triglyceride (MCT) 4 microlitres per kilogram of bodyweight in a home setting.
At baseline completing an online food frequency questionnaire.
At baseline and 1month- end of study,
- providing two non-consecutive days 24 hour dietary intake information
- collecting a faecal sample at home in an all in one kit
- having a blood sample taken by a paediatric experienced phlebotomist for serum Mk7 and three functional Vitamin K status markers, being protein induced in Vitamin K absence/deficiency (PIVKA-II), undercarboxylated osteocalcin (ucOC)/Osteocalcin (OC)/ ratio (UCR), and undercarboxylated Matrix-Gla protein (uc-MGP)
- having a finger reflection spectroscopy reading using Veggie Meter Registered Trademark as RS units
- having an anthropometry (weight using scales, height using stadiometer, body composition using a stand on bioelectrical impedance analysis machine, waist circumference using a tape measure and hand grip strength using a dynamometer), assessment done
Compliance assessment - daily intake record and volume remaining on return of supplement at end of study visit.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Mk7 supplement bioavailability
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Assessment method [1]
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Serum Mk7
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Timepoint [1]
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Baseline and end of Intervention at 1 month
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Primary outcome [2]
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Mk7 supplement affect on Vitamin K Status compared to placebo
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Assessment method [2]
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Serum PIVKA-II, ucOC + OC - ratio, uc-MGP
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Timepoint [2]
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Baseline and end of intervention at 1month
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Secondary outcome [1]
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Nil.
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Assessment method [1]
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Nil.
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Timepoint [1]
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Nil.
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Eligibility
Key inclusion criteria
Aged 4 to 17 years of age
Healthy - no active diseases
Participant plus parent consent and support
Able to attend Joondalup Health Campus in person at baseline and 1 month end of study
Agreeable to provide two blood samples
Agreeable to take supplement drops daily for 1 month
Agreeable to provide food intake information
Agreeable to collect two faecal samples at home with kit provided
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Minimum age
4
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Taking any of the following in the previous month - steroids, anti-coagulant medication, cholesterol lowering medication, antibiotic, high dose Vitamin E supplement and plant sterol supplement,
History of Liver disease, Inflammatory Bowel disease, or severe malabsorptive gastrointestinal disease (e.g. Short Bowel Syndrome)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Bio-availability
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Statistical methods / analysis
1) Wilcoxon Signed rank test for comparison of pre and end of study Serum Mk7, PIVKA-II, ucOC/OC/UCR and ucMGP in Intervention group
2) Mann-Whitney U-test for comparison between intervention and placebo differences at baseline and end of study for Serum Mk7, PIVKA-II, ucOC/OC/UCR and ucMGP.
3) Spearman's rho correlation for Vitamin K intake micrograms per kilogram and dietary scores
4) Spearman's rho correlation for Vitamin K intake and PIVKA-II, ucOC/OC/UCR, and uc-MGP
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/10/2025
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Actual
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Date of last participant enrolment
Anticipated
24/11/2025
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Actual
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Date of last data collection
Anticipated
20/12/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Western Australian Government - Future Health Research Innovation Fund
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Edith Cowan University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321498
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Country [1]
321498
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Other collaborator category [1]
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Hospital
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Name [1]
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Ramsay Health Care - Joondalup Health Campus
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Address [1]
283531
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Country [1]
283531
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Australia
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Other collaborator category [2]
283567
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Commercial sector/Industry
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Name [2]
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Balchem Corporation
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Address [2]
283567
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Country [2]
283567
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United States of America
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317641
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Ramsay Health Care WA / SA Human Research Ethics Committee
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Ethics committee address [1]
317641
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https://www.ramsayhealth.com.au/Ramsay-Research/Reseach-Ethics-at-Ramsay
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Ethics committee country [1]
317641
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Australia
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Date submitted for ethics approval [1]
317641
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16/06/2025
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Approval date [1]
317641
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Ethics approval number [1]
317641
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Summary
Brief summary
Menaquinone in Children (MIC) is a world-first study, being conducted in Western Australia, assessing the bioavailability of a Vitamin K- K2-Mk7 liquid supplement, assessing Vitamin K status using three functional markers as Vitamin K dependent proteins, and determining dietary Vitamin K1 and K2 intake using a new Australian foods Vitamin K database. It is a double-blind randomised control trial for 1 month of Vitamin K versus placebo in 50 healthy children and adolescents aged 4 to 17 years old. The intervention dosing is at 1.5 micrograms per kilogram of bodyweight.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Evania Marlow
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Address
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Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
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Country
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Australia
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Phone
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+61 0417185172
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Evania Marlow
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Address
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Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
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Country
141663
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Australia
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Phone
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+61 0417185172
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Fax
141663
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Email
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[email protected]
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Contact person for scientific queries
Name
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Evania Marlow
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Address
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Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
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Country
141664
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Australia
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Phone
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+61 0417185172
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Fax
141664
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Email
141664
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
No due to confidentiality and privacy. It will be group data being shared.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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