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The OK Daily Study

27. Mai 2026 aktualisiert von: Norfolk and Norwich University Hospitals NHS Foundation Trust

Oral Vitamin K2 (Menaquinone-7; MK-7) Supplementation and Effect on Vitamin K Status of Breastfed Term Infants in Early Infancy; a Four-cohort Prospective, Part-randomised, Part-blinded Study.

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The OK Daily Study is a multi-centre study taking place in the Norfolk and Norwich University Hospital, Norwich, UK, and Ashford and St Peters' Hospital, Chertsey, UK.

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.

Infants in the breastfeeding arm will be randomised into group 1 or group 2 in a 2:1 ratio. Group 1 allocation will be blinded; group 2 allocation will be open label.

  • Group 1 - infant supplementation group. Infants will receive either 45 micrograms/day of MK-7 with 10 micrograms/day vitamin D3 or a placebo consisting of 10 micrograms/day vitamin D3
  • Group 2 - maternal supplementation group. Mothers in this group will receive 2 mg/day MK-7. All breastfeeding infants in this group will receive 10 micrograms/day of vitamin D3.

Formula fed infants will be in group 3 and will not require any additional supplementation as part of this study. This is because infant formula is already supplemented with adequate amounts of vitamin K1 and vitamin D.

All supplements will be started within 7 days of birth. Vitamin D drops are included for breastfed infants as per national UK guidelines.

Follow up will be as follows:

  • 1 month postnatal visit (range 1-1.5 months) - phone call.

    o Confirmation of eligibility to continue, assessment of compliance with the intervention, and to schedule the in person follow up visit

  • 2 months postnatal (range 2-3 months) - in person visit.

    • All babies will have a single blood sample taken.
    • Mothers who are in group 2 (mothers who have had MK-7 supplementation) and a selection of mothers from group 1 (breastfeeding mothers who are not supplemented with MK-7) will have a single blood sample taken and will be asked to provide a single breastmilk sample
    • Mothers will be asked about their opinions on practising the supplementation.

Blood samples will be analysed for vitamin K status, including Proteins Induced by Vitamin K Absence/antagonism of prothrombin (PIVKA-II) and of osteocalcin (undercarboxylated osteocalcin), dephosphorylated-undercarboxylated matrix gla-protein (dp-ucMGP) and serum vitamin K concentrations (including of vitamin K1 and MK-7). Breastmilk samples will be analysed for vitamin K concentrations (including vitamin K1 and MK-7)

Once this in person follow up visit has been completed, the mother and baby pair will have completed the study.

Studientyp

Interventionell

Einschreibung (Geschätzt)

134

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Evidence of conjugated hyperbilirubinaemia (these babies are at higher risk of VKDB)
  • Mothers, and babies born to mothers, who are taking any medication that could affect or antagonise vitamin K metabolism (i.e. warfarin, the anti-epileptic drugs phenytoin or carbamazepine, and cephalosporin, rifampicin and isoniazid antimicrobials)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Mother and infant pairs who are breastfeeding.

Group 1 = infant supplementation group. Infants in this group will be randomised to receive either 6 drops a day containing 45 micrograms/day of MK-7 plus 10 micrograms/day vitamin D3 OR 10 micrograms/day vitamin D3 only (the active placebo, containing no vitamin K)

Group 2 = maternal supplementation group. Mothers in this group will be given 2 mg/day MK-7 capsules. Infants in this group will receive 10 micrograms/day vitamin D3.
Sonstiges: Combined MK-7 + vitamin D3 drops
6 drops/day providing 45 micrograms/day MK-7 plus 10 micrograms/day of vitamin D3
Andere Namen:
  • Vitamin K2 supplemented infant group
Sonstiges: Vitamin D3 Drops
6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7.
Andere Namen:
  • Vitamin K2 unsupplemented group
Sonstiges: MK-7 capsules
1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)
Aktiver Komparator: Formula Feeding Infants
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.
Sonstiges: Vitamin D3 Drops
6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7.
Andere Namen:
  • Vitamin K2 unsupplemented group

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants.
Zeitfenster: 2 months postnatal age (range 2-3 months).

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.
2 months postnatal age (range 2-3 months).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the various study groups.
Zeitfenster: 2 months postnatal age (range 2-3 months).

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.
2 months postnatal age (range 2-3 months).
Comparison of serum levels of osteocalcin (undercarboxylated and carboxylated) between the study groups.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Both undercarboxylated and carboxylated levels of osteocalcin will be measured in nanograms/mL.
2 months postnatal age (range 2-3 months).
Comparison of the percentage of undercarboxylated osteocalcin as a proportion of total osteocalcin (%GluOC) between the study groups.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Total osteocalcin calculated by the sum of the undercarboxylated and carboxylated osteocalcin values.
2 months postnatal age (range 2-3 months).
Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Measured in picomol/mL
2 months postnatal age (range 2-3 months).
Comparison of levels of serum K vitamers (including, but no limited to, vitamin K1 and menaquinone-7) between the study groups.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Serum K vitamers will be reported in micrograms/mL.
2 months postnatal age (range 2-3 months).
Comparison of the levels of breastmilk K vitamers (including, but not limited to, vitamin K1 and menaquinone-7) between unsupplemented and supplemented mothers.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Serum K vitamers will be reported in nanograms/mL
2 months postnatal age (range 2-3 months).
Investigation of percentage compliance to study supplementation.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Amount of remaining supplement will be assessed at follow up. This will then be used to calculate percentage compliance by comparing it to the expected volumes.
2 months postnatal age (range 2-3 months).
Investigation regarding families' opinions about infant and maternal vitamin supplementation.
Zeitfenster: 2 months postnatal age (range 2-3 months).
Measured via verbal questioning at follow up.
2 months postnatal age (range 2-3 months).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Mitarbeiter

Guy's and St Thomas' NHS Foundation Trust
University of East Anglia
Maastricht University
Ashford and St. Peter's Hospitals NHS Trust

Ermittler

  • Hauptermittler: Paul Clarke, Professor, Norfolk and Norwich University Hospitals Nhs Foundation Trust

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. August 2028

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 150-12-25

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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