[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638485":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":48,"studyPopulation":38,"armGroups":49,"interventions":62,"overallOfficials":79,"centralContacts":83,"locations":38,"responsibleParty":92,"collaborators":94,"id":103,"slug":38,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":38,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":38,"maxAge":111,"enrollmentInfo":112,"targetDuration":38,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":132,"whyStopped":38,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":38},{"fullName":5,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Comparison of the proportion of participants who have a PIVKA-II >0.05 AU\u002FmL in the unsupplemented and supplemented infants.","PIVKA-II = protein induced by vitamin K antagonism\u002Fabsence; clotting protein II.\n\nMeasured via serum blood sample in arbitrary units\u002FmL. For the primary outcome, this is the comparison between the supplemented and unsupplemented infants.","2 months postnatal age (range 2-3 months).",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Comparison of the proportion of participants who have a PIVKA-II >0.05 AU\u002FmL in the various study groups.","PIVKA-II = protein induced by vitamin K antagonism\u002Fabsence; clotting protein II.\n\nMeasured via serum blood sample in arbitrary units\u002FmL. For secondary outcome, this is comparison between remaining groups, other than those assessed in the primary outcome measure.",{"measure":18,"description":19,"timeFrame":12},"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\u002FmL.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups.","Measured in picomol\u002FmL",{"measure":27,"description":28,"timeFrame":12},"Comparison of levels of serum K vitamers (including, but no limited to, vitamin K1 and menaquinone-7) between the study groups.","Serum K vitamers will be reported in micrograms\u002FmL.",{"measure":30,"description":31,"timeFrame":12},"Comparison of the levels of breastmilk K vitamers (including, but not limited to, vitamin K1 and menaquinone-7) between unsupplemented and supplemented mothers.","Serum K vitamers will be reported in nanograms\u002FmL",{"measure":33,"description":34,"timeFrame":12},"Investigation of percentage compliance to study supplementation.","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.",{"measure":36,"description":37,"timeFrame":12},"Investigation regarding families' opinions about infant and maternal vitamin supplementation.","Measured via verbal questioning at follow up.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":44,"maskingDescription":45,"whoMasked":46},"SINGLE","Group 1 is double blinded. Groups 2 and 3 are open label by their nature.",[47],"INVESTIGATOR","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.\n\nInfants 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.\n\nThe 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.\n\nInfants 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.\n\n* Group 1 - infant supplementation group. Infants will receive either 45 micrograms\u002Fday of MK-7 with 10 micrograms\u002Fday vitamin D3 or a placebo consisting of 10 micrograms\u002Fday vitamin D3\n* Group 2 - maternal supplementation group. Mothers in this group will receive 2 mg\u002Fday MK-7. All breastfeeding infants in this group will receive 10 micrograms\u002Fday of vitamin D3.\n\nFormula 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.\n\nAll supplements will be started within 7 days of birth. Vitamin D drops are included for breastfed infants as per national UK guidelines.\n\nFollow up will be as follows:\n\n* 1 month postnatal visit (range 1-1.5 months) - phone call.\n\n  o Confirmation of eligibility to continue, assessment of compliance with the intervention, and to schedule the in person follow up visit\n* 2 months postnatal (range 2-3 months) - in person visit.\n\n  * All babies will have a single blood sample taken.\n  * 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\n  * Mothers will be asked about their opinions on practising the supplementation.\n\nBlood samples will be analysed for vitamin K status, including Proteins Induced by Vitamin K Absence\u002Fantagonism 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)\n\nOnce this in person follow up visit has been completed, the mother and baby pair will have completed the study.",[50,57],{"label":51,"type":6,"description":52,"interventionNames":53},"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.",[54,55,56],"Other: Combined MK-7 + vitamin D3 drops","Other: Vitamin D3 Drops","Other: MK-7 capsules",{"label":58,"type":59,"description":60,"interventionNames":61},"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.",[55],[63,69,75],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Combined MK-7 + vitamin D3 drops","6 drops\u002Fday providing 45 micrograms\u002Fday MK-7 plus 10 micrograms\u002Fday of vitamin D3",[51],[68],"Vitamin K2 supplemented infant group",{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Vitamin D3 Drops","6 drops\u002Fday providing 10 micrograms\u002Fday vitamin D3 and no supplementary MK-7.",[58,51],[74],"Vitamin K2 unsupplemented group",{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":38},"MK-7 capsules","1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)",[51],[80],{"name":81,"affiliation":5,"role":82},"Paul Clarke, Professor","PRINCIPAL_INVESTIGATOR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":38,"email":88},"Paul Professor Clarke","CONTACT","01603 286286","PAUL.CLARKE@nnuh.nhs.uk",{"name":90,"role":86,"phone":38,"phoneExt":38,"email":91},"Carianne Dr Lewis","Carianne.Lewis@nnuh.nhs.uk",{"type":93,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[95,97,99,101],{"name":96,"class":6},"Maastricht University",{"name":98,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":100,"class":6},"Ashford and St. Peter's Hospitals NHS Trust",{"name":102,"class":6},"University of East Anglia","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":113,"type":114},134,"ESTIMATED","INTERVENTIONAL",[117],"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.",[120,121],"Infant Vitamin K Status","Vitamin K Deficiency Bleeding",[123,124,125,126,127,128,129,130,131],"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":135,"type":136},"2026-06-02","ACTUAL",{"date":138,"type":114},"2026-08-01",{"date":140,"type":114},"2028-08-01",{"name":5,"class":6}]