Trial Review

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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.
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.
Secondary ID [1] 314493 0
G1006997
Universal Trial Number (UTN)
U1111-1323-0238
Trial acronym
MIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin K2-Mk7 intestinal absorption 337546 0
Vitamin K Status 337547 0
Dietary Vitamin K intake 337548 0
Normal Dietary Intake - all macro and micronutrients 337550 0
Anthropometry 337551 0
Immune health 337552 0
Intestinal Permeability 337554 0
Faecal Microbiome 337555 0
Vitamin K related genes 337557 0
Internal carotenoid status 337558 0
Condition category
Condition code
Diet and Nutrition 333904 333904 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 333905 333905 0 0
Normal oral and gastrointestinal development and function
Public Health 333906 333906 0 0
Other public health
Inflammatory and Immune System 333907 333907 0 0
Normal development and function of the immune system
Human Genetics and Inherited Disorders 333908 333908 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331122 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 341555 0
Mk7 supplement bioavailability
Timepoint [1] 341555 0
Baseline and end of Intervention at 1 month
Primary outcome [2] 341556 0
Mk7 supplement affect on Vitamin K Status compared to placebo
Timepoint [2] 341556 0
Baseline and end of intervention at 1month
Secondary outcome [1] 448786 0
Nil.
Timepoint [1] 448786 0
Nil.

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
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

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)
Sealed opaque envelopes.
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)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319033 0
Government body
Name [1] 319033 0
Western Australian Government - Future Health Research Innovation Fund
Country [1] 319033 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 321498 0
None
Name [1] 321498 0
Address [1] 321498 0
Country [1] 321498 0
Other collaborator category [1] 283531 0
Hospital
Name [1] 283531 0
Ramsay Health Care - Joondalup Health Campus
Address [1] 283531 0
Country [1] 283531 0
Australia
Other collaborator category [2] 283567 0
Commercial sector/Industry
Name [2] 283567 0
Balchem Corporation
Address [2] 283567 0
Country [2] 283567 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317641 0
Ramsay Health Care WA / SA Human Research Ethics Committee
Ethics committee address [1] 317641 0
Ethics committee country [1] 317641 0
Australia
Date submitted for ethics approval [1] 317641 0
16/06/2025
Approval date [1] 317641 0
Ethics approval number [1] 317641 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141662 0
Mrs Evania Marlow
Address 141662 0
Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
Country 141662 0
Australia
Phone 141662 0
+61 0417185172
Fax 141662 0
Email 141662 0
[email protected]
Contact person for public queries
Name 141663 0
Evania Marlow
Address 141663 0
Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
Country 141663 0
Australia
Phone 141663 0
+61 0417185172
Fax 141663 0
Email 141663 0
[email protected]
Contact person for scientific queries
Name 141664 0
Evania Marlow
Address 141664 0
Level 5, Building 21, SMHS, Edith Cowan University, 270 Joondalup Drive, EDGEWATER WA 6027
Country 141664 0
Australia
Phone 141664 0
+61 0417185172
Fax 141664 0
Email 141664 0
[email protected]

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.