[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325434":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":39,"responsibleParty":99,"collaborators":11,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Monthly bolus arm","EXPERIMENTAL",null,[13],"Drug: Monthly bolus of cholecalciferol per os",{"label":15,"type":10,"description":11,"interventionNames":16},"Daily arm",[17],"Drug: Daily dose of cholecalciferol per os",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Monthly bolus of cholecalciferol per os","Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Daily dose of cholecalciferol per os","Daily substitution, 1200 IU per day (4 drops), for 3 months",[15],[29],{"name":30,"affiliation":5,"role":31},"Carine Villanueva","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Carine Villanueva, MD","CONTACT","4 27 85 53 28","+33","carine.villanueva@chu-lyon.fr",[40,59,69,85],{"facility":41,"status":42,"city":43,"state":11,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est \u002F Hospices Civils de Lyon","RECRUITING","Bron","69677","France","FR",{"type":48,"coordinates":49},"Point",[50,51],4.91303,45.73865,{"lat":51,"lon":50},[54,58],{"name":55,"role":35,"phone":56,"phoneExt":37,"email":57},"Aurélie PORTEFAIX, Dr","04.72.35.75.51","aurelie.portefaix@chu-lyon.fr",{"name":55,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":60,"status":42,"city":43,"state":11,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},[65,68],{"name":66,"role":35,"phone":67,"phoneExt":37,"email":38},"Carinne VILLANUEVA, Dr","04 27 85 53 28",{"name":66,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":70,"status":71,"city":72,"state":11,"zip":73,"country":45,"countryCode":46,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand","NOT_YET_RECRUITING","Clermont-Ferrand","63000",{"type":48,"coordinates":75},[76,77],3.08682,45.77969,{"lat":77,"lon":76},[80,84],{"name":81,"role":35,"phone":82,"phoneExt":37,"email":83},"Charlotte CARDENOUX, Dr","04 73 75 00 00","ccardenoux@chu-clermontferrand.fr",{"name":81,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":86,"status":71,"city":87,"state":11,"zip":88,"country":45,"countryCode":46,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Centre Médical Infantile de Romagnat","Romagnat","63540",{"type":48,"coordinates":90},[91,92],3.10061,45.72955,{"lat":92,"lon":91},[95,98],{"name":81,"role":35,"phone":96,"phoneExt":37,"email":97},"04 73 62 76 17","c.cardenoux@centremedicalinfantile.com",{"name":81,"role":31,"phone":11,"phoneExt":11,"email":11},{"type":100,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100325434","phase-3-monthly-boluses-versus-daily-doses-for-correcting-blood-vitamin-d-deficit-in-obese-children-and-adolescents-100325434",false,"NCT03516968","Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents","Treatment of Vitamin D Deficit in Obese Children and Adolescents: an Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level: OBEVIDOS","OBEVIDOS","Inclusion Criteria:\n\n* Aged between 5 to 18 year-old\n* Being obese (BMI \\>97th percentile, \\> IOTF 30, for age and gender using the WHO references)\n* Patients (parents) having given their informed consent\n* Patient having insurance from the national health system\n\nExclusion Criteria:\n\nChildren will be excluded from the study if:\n\n* Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure)\n* Vitamin D supplementation in the 3 months preceding the inclusion visit (V1)\n* Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying)\n* Chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia (calcium \\> 2.65 mmol\u002FL), liver\u002Fkidney disease, malabsorption diseases;\n* Hypercalciuria (urinary Calcium\u002FCreatinine \\> 0.7 mmol\u002Fmmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D \\> 250 nmol\u002FL); nephrocalcinosis;\n* Ongoing treatment with anticonvulsants\u002Fbarbiturates or steroids which increase the catabolism of 25(OH)D;\n* Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium;\n* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;\n* Pregnancy, breastfeeding;\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;\n* Simultaneous enrolment to another study which could influence the results of the current study;\n* Patient under legal protection or deprived of liberty.","ALL","5 Years","18 Years",{"count":113,"type":114},68,"ESTIMATED","INTERVENTIONAL",[117],"PHASE3","Childhood obesity is one of the most serious public health challenges of the 21st century, with an increasing prevalence over time in developed countries. Overweight and obese children and adolescents are likely to remain so into adulthood and to develop chronic diseases at a young age, such as diabetes and cardiovascular disease.\n\nObese patients, whether adults or children, are likely to have low serum vitamin D levels due to sequestration and\u002For volumetric dilution of this fat-soluble vitamin in adipose tissue. Studies have established a link between vitamin D deficiency or insufficiency and chronic diseases such as hypertension, type 2 diabetes and other metabolic problems.\n\nDetermining physiological 25(OH)D levels to ensure optimal phosphocalcic metabolism and bone mineralisation requires the use of functional markers: parathyroid hormone (PTH) levels, assessment of the intestinal calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry.\n\nVitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels.\n\nEach unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation.\n\nThe latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU\u002Fday for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks.\n\nThere are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.",[120],"Obesity, Childhood",[122,123,124,125,126],"Obesity","Vitamin D deficiency,","supplementation,","Child","Adolescent","2025-06-10",{"date":129,"type":130},"2025-06-13","ACTUAL",{"date":132,"type":130},"2023-12-04",{"date":134,"type":114},"2027-03",{"name":5,"class":6},4]