"Vitamin C Deficiency in Hospitalized Adults: Systematic Screening Vs. Traditional Judgment - a Before-and-After Observational Study"

Официальное название

Identification of Vitamin C Deficiency in Hospitalized Adults Through a Systematic Approach Vs. Traditional Medical Judgment: a Before-and-After Observational Study

Обзор

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. The main questions it aims to answer are: What 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. Study Design Participants will: Be hospitalized adults (≥18 years old) presenting with documented micro- or macroscopic hemorrhagic signs. Undergo vitamin C level assessment either as part of the standardized screening protocol (prospective arm) or based on physician judgment (retrospective control group). Have additional clinical and laboratory data collected, including hemoglobin levels, platelet count, iron status, vitamin B9/B12 levels, and other relevant parameters. This 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.

Подробное описание

Study Design and Methodology

Study Type:

Observational (before-after study design)

Retrospective for the control group (patients with historical vitamin C measurements) and for exposure group (patients systematically screened based on predefined hemorrhagic criteria)

Study Population:

Inclusion Criteria:

Adults (age ≥18 years) admitted to the hospital

Presence of micro- or macroscopic hemorrhagic symptoms

Undergoing vitamin C level assessment (either systematic or based on physician discretion)

Exclusion Criteria:

Refusal to participate

Prior vitamin C supplementation within one month before the study period

Study Groups:

Control Group (Retrospective):

Patients with documented hemorrhagic symptoms for whom vitamin C levels were measured based on physician judgment (prior to implementation of systematic screening criteria).

Exposure Group (Prospective):

Patients identified through a systematic screening protocol incorporating predefined hemorrhagic criteria.

Primary Outcome:

Incidence of vitamin C deficiency (defined as serum ascorbic acid levels below laboratory reference ranges) in patients with hemorrhagic symptoms.

Secondary Outcomes:

Diagnostic efficiency of the systematic screening approach versus traditional physician-led assessment.

Association between vitamin C deficiency and anemia (hemoglobin levels, mean corpuscular volume, ferritin, reticulocyte count, transferrin saturation).

Association with other micronutrient deficiencies (folate, B12, albumin, and iron status).

Presence of concurrent infections in vitamin C-deficient patients.

Impact on hospital length of stay in vitamin C-deficient patients versus non-deficient patients.

Data Collection and Registry Procedures

Quality Assurance Plan:

Data validation and registry procedures include automated and manual data checks for completeness and consistency.

On-site data audits will be conducted to ensure compliance with study protocols.

Standardized case report forms (CRFs) will be used for data collection.

Data Verification and Source Validation:

Data consistency checks will compare registry entries with patient medical records.

Laboratory values will be cross-validated against hospital electronic records.

External source verification will be conducted for select cases to assess data accuracy.

Standard Operating Procedures (SOPs):

Patient Recruitment: Patients meeting inclusion criteria will be identified through hospital electronic records and physician referrals.

Data Collection:

Baseline assessment will include demographic details, medical history, and medication use (e.g., anticoagulants, nutritional supplements).

Clinical evaluation will include hemorrhagic symptoms (ecchymosis, petechiae, gastrointestinal bleeding, hematuria, epistaxis).

Laboratory assessments will include vitamin C levels, hemoglobin, ferritin, folate, B12, albumin, and markers of infection.

Вмешательства

• Диагностический тест systematical screening of at risk patients based on predefined hemorrhagic criteria
  Patients selected if condition present: Hematuria (blood in urine) Macroscopic hematuria (visible blood in urine) Hematuria detected by urine dipstick or microscopic analysis Ecchymoses (bruising) Epistaxis (nosebleeds) Petechiae (small pinpoint hemorrhages on the skin) Gastrointestinal bleeding Upper GI bleeding: Hematemesis (vomiting blood) Lower GI bleeding: Melena (black tarry stools) Positive fecal occult blood test (FOBT) Cerebral hemorrhage (brain bleeding)

Первичные конечные точки

• The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs. [Срок оценки: 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.]

Критерии участия

Критерии включения

Hospitalized adult patients (≥18 years old) who had Vitamin C testing performed during their hospital stay.

Documented hemorrhagic manifestations in medical records, including at least one of the following:

Hematuria (macroscopic or detected via urine dipstick/microscopy). Ecchymoses (bruising). Petechiae. Epistaxis (nosebleeds). Gastrointestinal bleeding (melena, hematemesis, or positive fecal occult blood test).

Cerebral hemorrhage. Medical records available with sufficient clinical and laboratory data to assess eligibility and study variables.

Patients from two distinct periods:

Historical Control Group: Patients tested for Vitamin C "as needed" based on traditional medical judgment.

Active Group: Patients tested systematically according to Scurvy Suspicion upon Hemorrhagic Risk (SFI) criteria after protocol implementation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• Gueret Hospital — Guéret

Идентификаторы

NCT: NCT06876545 · A001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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