[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638485":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":42,"locations":37,"responsibleParty":51,"collaborators":53,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":37,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":37,"maxAge":71,"enrollmentInfo":72,"targetDuration":37,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":92,"whyStopped":37,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":37},{"fullName":5,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"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\u002Fday of MK-7 plus 10 micrograms\u002Fday vitamin D3 OR 10 micrograms\u002Fday vitamin D3 only (the active placebo, containing no vitamin K)\n\nGroup 2 = maternal supplementation group. Mothers in this group will be given 2 mg\u002Fday MK-7 capsules. Infants in this group will receive 10 micrograms\u002Fday vitamin D3.",[12,13,14],"Other: Combined MK-7 + vitamin D3 drops","Other: Vitamin D3 Drops","Other: MK-7 capsules",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[13],[21,27,33],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Combined MK-7 + vitamin D3 drops","6 drops\u002Fday providing 45 micrograms\u002Fday MK-7 plus 10 micrograms\u002Fday of vitamin D3",[9],[26],"Vitamin K2 supplemented infant group",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Vitamin D3 Drops","6 drops\u002Fday providing 10 micrograms\u002Fday vitamin D3 and no supplementary MK-7.",[16,9],[32],"Vitamin K2 unsupplemented group",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"MK-7 capsules","1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)",[9],null,[39],{"name":40,"affiliation":5,"role":41},"Paul Clarke, Professor","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":37,"email":47},"Paul Professor Clarke","CONTACT","01603 286286","PAUL.CLARKE@nnuh.nhs.uk",{"name":49,"role":45,"phone":37,"phoneExt":37,"email":50},"Carianne Dr Lewis","Carianne.Lewis@nnuh.nhs.uk",{"type":52,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[54,56,58,60],{"name":55,"class":6},"Maastricht University",{"name":57,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":59,"class":6},"Ashford and St. Peter's Hospitals NHS Trust",{"name":61,"class":6},"University of East Anglia","100638485","the-ok-daily-study-100638485",false,"NCT07620236","The OK Daily Study","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.","Inclusion Criteria:\n\n* Infants, and mothers of infants, born ≥37 weeks gestational age\n* Standard dose of intramuscular (IM) vitamin K prophylaxis given to the neonate following birth\n* For breastfeeding mothers: the mother intends to exclusively\u002Fpredominantly breastfeed their baby for at least 2 months\n\nExclusion Criteria:\n\n* Inability or refusal to provide informed consent\n* Inability to adhere to or comply with study procedures\n* 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\n* 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)\n* Evidence of conjugated hyperbilirubinaemia (these babies are at higher risk of VKDB)\n* 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)",true,"ALL","7 Days",{"count":73,"type":74},134,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThe overall aims are:\n\n* To compare infant MK-7 supplementation with placebo\n* To compare maternal MK-7 supplementation with placebo\n* To compare infant MK-7 supplementation and maternal MK-7 supplementation\n* To compare infant MK-7 supplementation with vitamin K1 supplementation via infant formula milk.\n\nOnce 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.\n\nFollow 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.",[80,81],"Infant Vitamin K Status","Vitamin K Deficiency Bleeding",[83,84,85,86,87,88,89,90,91],"Oral vitamin K","vitamin K1 vs K2","menaquinone-7 (MK-7)","vitamin K status","PIVKA-II","undercarboxylated\u002Fcarboxylated osteocalcin ratio","neonate","infant","breastfeeding","NOT_YET_RECRUITING","2026-05-27",{"date":95,"type":96},"2026-06-02","ACTUAL",{"date":98,"type":74},"2026-08-01",{"date":100,"type":74},"2028-08-01",{"name":5,"class":6}]