[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vitamin-b-12-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vitamin-b-12-deficiency":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100605549","the-b-babies-study-an-observational-study-of-group-b-vitamins-in-preterm-infants-100605549",false,"NCT07163962","THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants","Maternal, Milk and Baby Markers of Group B Vitamin Metabolism in (Very) Preterm Infants at the Time of Discharge Home","B-BABIES","Inclusion Criteria:\n\n* Gestational age at birth \\\u003C37 weeks.\n* Admission to one of the participating units.\n* Full enteral milk feeds established by suck\u002Fnasogastric tube\n\nExclusion Criteria:\n\n* Known or suspected chromosomal, genetic or metabolic abnormalities.\n* Major congenital malformations\n* Any intercurrent condition that precludes implementation of standard feeding protocols and requires specialized formulas or changes in standard vitamin supplementation.\n* Any intercurrent condition that will interfere with the interpretation of results (renal impairment and hypothyroidism can lead to elevated tHcy and MMA, for example).","ALL","28 Days",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth across the lifespan. Folate and vitamin B12 are essential in development, and preterm infants may be particularly susceptible to deficiencies. This is the result of a combination of low stores and high requirements for fast growth and rapid red blood cell production in the context of multifactorial anaemia of prematurity. Micronutrient supply, including vitamin B12 and folate, is delivered through nutritional support, in the shape of parenteral nutrition, fortification of human milk of use of artificial formula. Most of this supplementation will be interrupted by the time the infant is getting ready for discharge home. The investigators previously reported high levels of serum folate in preterm infants at the time of discharge home and in early infancy, but there are no contemporary studies investigating the vitamin B12\u002Ffolate status in this population. The investigators aim to investigate the prevalence of vitamin B12 deficiency in preterm infants at the time of discharge home.",[25],"Vitamin B-12 Deficiency",[27,28,29,30,31,32],"Preterm infant","vitamin B12","Folate","Folic acid","Vitamin deficiency","Micronutrition","NOT_YET_RECRUITING","2025-09-05",{"date":36,"type":37},"2025-09-09","ACTUAL",{"date":39,"type":21},"2025-09-01",{"date":41,"type":21},"2026-09-30",{"name":43,"class":44},"Norfolk and Norwich University Hospitals NHS Foundation Trust","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100519680","diet-quality-of-pregnant-women-with-a-strict-plant-based-diet-versus-an-omnivorous-diet-100519680","NCT06046703","Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet","Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet: a Focus on Vitamin B12 Intake and Other Nutritional and Pregnancy-related Outcomes","Inclusion Criteria:\n\n* Before 27 weeks of pregnancy\n* Age \\>18 years\n* Strict plant-based diet (vegan diet), defined as a diet without ingestion of animal products (i.e., intake less than once a month during) the entire pregnancy or omnivorous diet, defined as a diet that includes meat\n* Willing and able to give written informed consent and to understand, participate and comply with the research project requirements\n\nExclusion Criteria:\n\n* Food allergy that influences the nutritional intake, e.g., milk allergy, celiac disease, and lactose intolerance\n* Medical history of gastrointestinal diseases such as Crohn's disease and other diseases associated with vitamin B12 deficiencies such as (pre-existing) diabetes.\n* Medical history of abdominal surgery interfering with nutrient uptake, such as gastric bypass and intestinal resections\n* Pre-existing cardio-vascular diseases or auto-immune diseases\n* Insufficient understanding of the Dutch language","FEMALE","18 Years",{"count":56,"type":21},256,"The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet.\n\nThe main aim is to compare vitamin B12 intake.\n\nParticipants will be asked to:\n\n* fill out a health questionnaire\n* fill out a three-day food diary\n* undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.",[59,60,61,62],"Vitamin B 12 Deficiency","Pregnancy","Nutrient Deficiency","Dietary Exposure",[64,65,66,67,68],"vegan diet","pregnancy","vitamin b12","omnivorous","nutrition","2024-03-12",{"date":71,"type":37},"2024-03-13",{"date":73,"type":21},"2025-01-01",{"date":75,"type":21},"2027-07-01",{"name":77,"class":44},"Maastricht University Medical Center",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":45},"100439715","phase-2-early-infant-micronutrition-and-development-100439715","NCT05005897","Early Infant Micronutrition and Development","Vitamin B12 Status in Infancy and the Effect of Providing Vitamin B12 to Infants With Signs of Suboptimal Vitamin B12 Status - a Registry-based, Randomized Controlled Trial","RART","Inclusion Criteria:\n\n1. Availability of informed verbal consent\n2. Plan to reside in the defined study area for the next 12 months\n3. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months\n\nExclusion Criteria:\n\n1. Severe systemic illness requiring hospitalization\n2. Growth retardation\n3. Severe congenital malformations\n4. Plasma cobalamin concentration \\\u003C148 pmol\u002FL (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)","1 Month","2 Months",{"count":89,"type":21},600,"INTERVENTIONAL",[92,93],"PHASE2","PHASE3","Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes.\n\nStudy design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year).\n\nPregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin.\n\nInfants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group.\n\nOutcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life",[59],[97,98,99,100,101,102,103],"Nutrition","Vitamins","Breastfeeding","Infant","Neurodevelopment","Growth","Clinical trial","RECRUITING","2023-04-14",{"date":107,"type":37},"2023-04-18",{"date":109,"type":37},"2021-12-08",{"date":111,"type":21},"2029-10-15",{"name":113,"class":44},"Sykehuset Innlandet HF"]