The OK Daily Study

Summary

The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or breastfeeding mothers to see whether this improves the incidence of biochemical vitamin K deficiency in the infants at 2 months postnatal age.

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.

Once recruited, mother and infant pairs will be grouped initially based on the families' feeding choice. Breastfed infants will then be randomised 2:1 to the infant supplementation or maternal supplementation group. Within the infant supplementation group, infants will either receive MK-7 with vitamin D or a placebo containing vitamin D.

Follow up will occur at 2 months postnatal age (range 2-3 months postnatal age), where bloods and breastmilk samples will be collected to assess the infant and maternal vitamin K status.

Conditions

• Infant Vitamin K Status
• Vitamin K Deficiency Bleeding

Interventions

OTHER

Combined MK-7 + vitamin D3 drops

6 drops/day providing 45 micrograms/day MK-7 plus 10 micrograms/day of vitamin D3

OTHER

Vitamin D3 Drops

6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7.

OTHER

MK-7 capsules

1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)

Sponsors & Collaborators

• Maastricht University

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Ashford and St. Peter's Hospitals NHS Trust

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Paul Clarke, Professor · Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

7 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-09-01

Completion

2028-08-01