The OK Daily Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 7
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants, and mothers of infants, born ≥37 weeks gestational age
Standard dose of intramuscular (IM) vitamin K prophylaxis given to the neonate following birth
For breastfeeding mothers: the mother intends to exclusively/predominantly breastfeed their baby for at least 2 months
Disqualifiers
Inability or refusal to provide informed consent
Inability to adhere to or comply with study procedures
Babies who meet the inclusion gestation but would otherwise, as part of routine neonatal care, be provided with daily vitamin K drops (i.e. NeoKay drops) at discharge
IM vitamin K prophylaxis not received at birth (parents declined vitamin K prophylaxis or parents chose for neonate to receive an oral course of vitamin K prophylaxis instead)
Trial design
Design model
Parallel
Treatments tested in this trial
Combined MK-7 + vitamin D3 drops
Other intervention6 drops/day providing 45 micrograms/day MK-7 plus 10 micrograms/day of vitamin D3
Vitamin D3 Drops
Other intervention6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7.
MK-7 capsules
Other intervention1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Mother and infant pairs who are breastfeeding.Other 3 interventions
Group B: Formula Feeding InfantsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants.
PIVKA-II = protein induced by vitamin K antagonism/absence; clotting protein II. Measured via serum blood sample in arbitrary units/mL. For the primary outcome, this is the comparison between the supplemented and unsupplemented infants.
Time frame
2 months postnatal age (range 2-3 months).Secondary outcomes
1
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the various study groups.
PIVKA-II = protein induced by vitamin K antagonism/absence; clotting protein II. Measured via serum blood sample in arbitrary units/mL. For secondary outcome, this is comparison between remaining groups, other than those assessed in the primary outcome measure.
Time frame
2 months postnatal age (range 2-3 months).2
Comparison of serum levels of osteocalcin (undercarboxylated and carboxylated) between the study groups.
Both undercarboxylated and carboxylated levels of osteocalcin will be measured in nanograms/mL.
Time frame
2 months postnatal age (range 2-3 months).3
Comparison of the percentage of undercarboxylated osteocalcin as a proportion of total osteocalcin (%GluOC) between the study groups.
Total osteocalcin calculated by the sum of the undercarboxylated and carboxylated osteocalcin values.
Time frame
2 months postnatal age (range 2-3 months).4
Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups.
Measured in picomol/mL
Time frame
2 months postnatal age (range 2-3 months).Locations
Sponsors and contacts
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Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead sponsor
Maastricht University
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Ashford and St. Peter's Hospitals NHS Trust
Collaborator
University of East Anglia
Collaborator
Source ClinicalTrials.gov
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