[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-vitamin-k-status\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-vitamin-k-status":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"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":20,"type":21},134,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Infant Vitamin K Status","Vitamin K Deficiency Bleeding",[30,31,32,33,34,35,36,37,38],"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":42,"type":43},"2026-06-02","ACTUAL",{"date":45,"type":21},"2026-08-01",{"date":47,"type":21},"2028-08-01",{"name":49,"class":50},"Norfolk and Norwich University Hospitals NHS Foundation Trust","OTHER"]