None listed
Conditions
Brief summary
Menaquinone in Children (MIC) is a world-first study, being conducted in Western Australia, assessing the effectiveness 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.
Interventions
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
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.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 17 Years
Healthy volunteers
Yes
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
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)
Outcome results
None listed