[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583455":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":15,"studyPopulation":16,"armGroups":17,"interventions":26,"overallOfficials":32,"centralContacts":43,"locations":52,"responsibleParty":66,"collaborators":69,"id":72,"slug":13,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":13,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":13,"enrollmentInfo":80,"targetDuration":13,"studyType":83,"phases":13,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":89,"whyStopped":13,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Internist.Ro","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.","Definition of the Primary Outcome:\n\nVitamin C deficiency will be determined based on serum ascorbic acid levels measured through blood sampling.\n\nA deficient status is defined as a serum ascorbic acid concentration below the reference values established by the central laboratory (Cerba, Paris, France).\n\nOnly samples processed within 2 hours of collection will be considered valid due to the instability of ascorbic acid.","The total study duration is expected to be around 4 months (3 months retrospective + 1 month prospective), but data collection may continue if necessary to reach the required sample size.",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":6,"timePerspective":6,"maskingInfo":13},"Study Design and Methodology\n\nStudy Type:\n\nObservational (before-after study design)\n\nRetrospective for the control group (patients with historical vitamin C measurements) and for exposure group (patients systematically screened based on predefined hemorrhagic criteria)\n\nStudy Population:\n\nInclusion Criteria:\n\nAdults (age ≥18 years) admitted to the hospital\n\nPresence of micro- or macroscopic hemorrhagic symptoms\n\nUndergoing vitamin C level assessment (either systematic or based on physician discretion)\n\nExclusion Criteria:\n\nRefusal to participate\n\nPrior vitamin C supplementation within one month before the study period\n\nStudy Groups:\n\nControl Group (Retrospective):\n\nPatients with documented hemorrhagic symptoms for whom vitamin C levels were measured based on physician judgment (prior to implementation of systematic screening criteria).\n\nExposure Group (Prospective):\n\nPatients identified through a systematic screening protocol incorporating predefined hemorrhagic criteria.\n\nPrimary Outcome:\n\nIncidence of vitamin C deficiency (defined as serum ascorbic acid levels below laboratory reference ranges) in patients with hemorrhagic symptoms.\n\nSecondary Outcomes:\n\nDiagnostic efficiency of the systematic screening approach versus traditional physician-led assessment.\n\nAssociation between vitamin C deficiency and anemia (hemoglobin levels, mean corpuscular volume, ferritin, reticulocyte count, transferrin saturation).\n\nAssociation with other micronutrient deficiencies (folate, B12, albumin, and iron status).\n\nPresence of concurrent infections in vitamin C-deficient patients.\n\nImpact on hospital length of stay in vitamin C-deficient patients versus non-deficient patients.\n\nData Collection and Registry Procedures\n\nQuality Assurance Plan:\n\nData validation and registry procedures include automated and manual data checks for completeness and consistency.\n\nOn-site data audits will be conducted to ensure compliance with study protocols.\n\nStandardized case report forms (CRFs) will be used for data collection.\n\nData Verification and Source Validation:\n\nData consistency checks will compare registry entries with patient medical records.\n\nLaboratory values will be cross-validated against hospital electronic records.\n\nExternal source verification will be conducted for select cases to assess data accuracy.\n\nStandard Operating Procedures (SOPs):\n\nPatient Recruitment: Patients meeting inclusion criteria will be identified through hospital electronic records and physician referrals.\n\nData Collection:\n\nBaseline assessment will include demographic details, medical history, and medication use (e.g., anticoagulants, nutritional supplements).\n\nClinical evaluation will include hemorrhagic symptoms (ecchymosis, petechiae, gastrointestinal bleeding, hematuria, epistaxis).\n\nLaboratory assessments will include vitamin C levels, hemoglobin, ferritin, folate, B12, albumin, and markers of infection.\n\nData Management:\n\nDe-identified patient data will be stored in a secure, access-controlled database.\n\nRoutine data audits will ensure quality and completeness.\n\nStatistical Analysis:\n\nData will be analyzed per predefined statistical models to assess prevalence and associations.\n\nSample Size Assessment:\n\nEstimated 42 patients per group based on prevalence estimates of 20% vitamin C deficiency in hospitalized patients with hemorrhagic symptoms.\n\nSample size determination accounts for a power of 80% and alpha of 0.05.\n\nBayesian inference will be applied if sample size calculations require adjustments based on interim analyses.\n\nPlan for Handling Missing Data:\n\nImputation methods (multiple imputations) will be used for missing laboratory values.\n\nSensitivity analyses will assess the impact of missing data on study conclusions.\n\nStatistical Analysis Plan:\n\nDescriptive Statistics:\n\nMean, median, standard deviation for continuous variables.\n\nFrequency distribution for categorical variables.\n\nComparative Analyses:\n\nStudent's t-test or Mann-Whitney U test for continuous variables.\n\nChi-square or Fisher's exact test for categorical variables.\n\nMultivariable Regression Models:\n\nAdjustments for confounders (age, comorbidities, nutritional status, anticoagulant use).\n\nLogistic regression for risk factor analysis of vitamin C deficiency.\n\nCox proportional hazards model for hospital length of stay impact analysis.\n\nSensitivity Analyses:\n\nAssess variations in vitamin C deficiency prevalence.\n\nEvaluate changes in detection efficiency of systematic screening protocol.\n\nEthical Considerations\n\nThe study is non-interventional and does not alter clinical care.\n\nPatient confidentiality will be ensured through anonymized data collection and secure storage.\n\nInformed consent will be obtained for prospective participants.\n\nThe study has received ethical approval from the Centre Hospitalier de Guéret Ethics Committee.\n\nData Dissemination Plan\n\nResults will be published in peer-reviewed medical journals.\n\nFindings will be shared with hospital medical teams to optimize patient care.\n\nA summary report will be provided to participants upon study completion.\n\nConclusion\n\nThis study will provide critical insights into the prevalence of vitamin C deficiency in hospitalized patients with hemorrhagic symptoms. By evaluating a structured screening approach, this research aims to improve early detection and clinical awareness of vitamin C deficiency, potentially informing future guidelines for at-risk populations.","Patients who received Vitamin C supplementation within the month prior to testing.\n\nIncomplete or missing medical records regarding hemorrhagic manifestations or Vitamin C test results.\n\nHemorrhagic events clearly attributable to anticoagulant or antiplatelet overdose, without other potential contributing factors.\n\nBlood samples processed more than 2 hours after collection, making Vitamin C levels unreliable.",[18,21],{"label":19,"type":13,"description":20,"interventionNames":13},"Historical control group","Control Group (Historical Cohort):\n\nPatients who underwent Vitamin C testing based on traditional clinical judgment, meaning testing was performed \"as needed\" at the discretion of the treating physician.\n\nNo standardized criteria were applied for selecting patients for Vitamin C testing.\n\nData will be collected from medical records retrospectively (prior to the introduction of a systematic screening approach).",{"label":22,"type":13,"description":23,"interventionNames":24},"Prospective Cohort","Active Group (Systematic Screening Cohort):\n\nPatients who underwent Vitamin C testing based on a predefined, rigorous suspicion framework (SFI - Scurvy Suspected upon Hemorrhagic Risk).\n\nTesting was systematically performed in patients with predefined hemorrhagic risk factors, including:\n\nHematuria (macroscopic or detected via dipstick\u002Fmicroscopy). Ecchymoses (bruising). Petechiae. Epistaxis. Gastrointestinal bleeding (melena, hematemesis, positive fecal occult blood test).\n\nCerebral hemorrhage. The selection for testing was systematic and protocol-driven, ensuring a more structured and standardized approach.",[25],"Diagnostic Test: systematical screening of at risk patients based on predefined hemorrhagic criteria",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"DIAGNOSTIC_TEST","systematical screening of at risk patients based on predefined hemorrhagic criteria","Patients selected if condition present:\n\nHematuria (blood in urine)\n\nMacroscopic hematuria (visible blood in urine) Hematuria detected by urine dipstick or microscopic analysis Ecchymoses (bruising)\n\nEpistaxis (nosebleeds)\n\nPetechiae (small pinpoint hemorrhages on the skin)\n\nGastrointestinal bleeding\n\nUpper GI bleeding: Hematemesis (vomiting blood) Lower GI bleeding: Melena (black tarry stools) Positive fecal occult blood test (FOBT) Cerebral hemorrhage (brain bleeding)",[22],[33,37,40],{"name":34,"affiliation":35,"role":36},"Adrian Purcarea MD","Transylvania Univeristy, Faculty of Medicine, Brasov, Romania","STUDY_DIRECTOR",{"name":38,"affiliation":35,"role":39},"Silvia Sovaila MD","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Remy Bouquet MD","Gueret Hospital, Creuse, France",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":13,"email":48},"Adrian PURCAREA MD","CONTACT","0040751141636","adrian.purcarea@internist.ro",{"name":38,"role":46,"phone":50,"phoneExt":13,"email":51},"0040753020253","sovaila.silvia@gmail.com",[53],{"facility":54,"status":13,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":13},"Gueret Hospital","Guéret","Creuse","23000","France","FR",{"type":61,"coordinates":62},"Point",[63,64],1.87166,46.17185,{"lat":64,"lon":63},{"type":39,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Purcarea Adrian","MD, PhD",[70],{"name":71,"class":6},"Centre Hospital Regional Universitaire de Limoges","100583455",false,"NCT06876545","\"Vitamin C Deficiency in Hospitalized Adults: Systematic Screening Vs. Traditional Judgment - a Before-and-After Observational Study\"","Identification of Vitamin C Deficiency in Hospitalized Adults Through a Systematic Approach Vs. Traditional Medical Judgment: a Before-and-After Observational Study","Inclusion Criteria:\n\nHospitalized adult patients (≥18 years old) who had Vitamin C testing performed during their hospital stay.\n\nDocumented hemorrhagic manifestations in medical records, including at least one of the following:\n\nHematuria (macroscopic or detected via urine dipstick\u002Fmicroscopy). Ecchymoses (bruising). Petechiae. Epistaxis (nosebleeds). Gastrointestinal bleeding (melena, hematemesis, or positive fecal occult blood test).\n\nCerebral hemorrhage. Medical records available with sufficient clinical and laboratory data to assess eligibility and study variables.\n\nPatients from two distinct periods:\n\nHistorical Control Group: Patients tested for Vitamin C \"as needed\" based on traditional medical judgment.\n\nActive Group: Patients tested systematically according to Scurvy Suspicion upon Hemorrhagic Risk (SFI) criteria after protocol implementation.","ALL","18 Years",{"count":81,"type":82},150,"ESTIMATED","OBSERVATIONAL","Brief Summary of the Study The goal of this observational study is to assess the incidence of vitamin C deficiency among hospitalized adults presenting with hemorrhagic signs. The study will also evaluate the effectiveness of a standardized screening protocol compared to traditional clinical judgment.\n\nThe main questions it aims to answer are:\n\nWhat is the incidence of vitamin C deficiency in hospitalized patients with hemorrhagic symptoms? Is a standardized screening protocol more effective than traditional clinical judgment in identifying vitamin C deficiency? Is vitamin C deficiency associated with anemia, other micronutrient deficiencies (folate, B12, albumin, iron), or infectious conditions? Does vitamin C deficiency impact hospital length of stay? Researchers will compare a systematic screening approach based on predefined hemorrhagic criteria (e.g., hematuria, ecchymosis, epistaxis, petechiae, gastrointestinal bleeding, or intracranial hemorrhage) to the traditional physician-judgment approach to determine its effectiveness in identifying vitamin C deficiency.\n\nStudy Design\n\nParticipants will:\n\nBe hospitalized adults (≥18 years old) presenting with documented micro- or macroscopic hemorrhagic signs.\n\nUndergo vitamin C level assessment either as part of the standardized screening protocol (prospective arm) or based on physician judgment (retrospective control group).\n\nHave additional clinical and laboratory data collected, including hemoglobin levels, platelet count, iron status, vitamin B9\u002FB12 levels, and other relevant parameters.\n\nThis non-interventional study will not modify the standard of care but will systematically assess the prevalence of vitamin C deficiency in at-risk patients and evaluate the utility of a structured screening protocol.",[86],"Scurvy",[88],"Scurvy, vitamin C defficiency, hospitalized","NOT_YET_RECRUITING","2025-03-10",{"date":92,"type":93},"2025-03-14","ACTUAL",{"date":95,"type":82},"2025-04-01",{"date":97,"type":82},"2025-04-30",{"name":5,"class":6},1]