The OK Daily Study

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study.

The overall aims are: * To compare infant MK-7 supplementation with placebo * To compare maternal MK-7 supplementation with placebo * To compare infant MK-7 supplementation and maternal MK-7 supplementation * To compare infant MK-7 supplementation with vitamin K1 supplementation via infant formula milk.

It had two arms (groups): Mother and infant pairs who are breastfeeding. (other) and Formula Feeding Infants (active comparator).

Infants who are exclusively formula feeding. These infants will receive the recommended daily amount of vitamin K through their formula milk intake and so will not receive any additional vitamin K supplementation.

The registry classes the interventions as other.

More on the Plan

Infants born at ≥37 weeks' gestation will be recruited in the participating site if they meet eligibility criteria and are born within the recruitment window.

Recruitment will take place before the mother and infant are discharged from the hospital following birth.

The two main arms of this study are breastfeeding and formula feeding.

Mother and infant pairs will initially be allocated based on the family's feeding preferences.

Who Took Part

The registry lists 134 planned participants were the target.

It was open to people of any sex aged up to 7 Days.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Infants, and mothers of infants, born ≥37 weeks gestational age. For breastfeeding mothers: the mother intends to exclusively/predominantly breastfeed their baby for at least 2 months.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: inability or refusal to provide informed consent; inability to adhere to or comply with study procedures; evidence of conjugated hyperbilirubinaemia (these babies are at higher risk of vkdb).

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

In this single-blind Vitamin D, K2, Magnesium and Zinc study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2026-10-01 with completion listed for 2027-09-01.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants (time frame: 2 months postnatal age (range 2-3 months)).

It also tracked 8 secondary outcomes, for example Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the various study groups, Comparison of serum levels of osteocalcin (undercarboxylated and carboxylated) between the study groups, Comparison of the percentage of undercarboxylated osteocalcin as a proportion of total osteocalcin (%GluOC) between the study groups, Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups, Comparison of levels of serum K vitamers (including, but no limited to, vitamin K1 and menaquinone-7) between the study groups and Investigation of percentage compliance to study supplementation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 134 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.