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

NCT06876545 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-14

No results posted yet for this study

Summary

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.

Conditions

  • Scurvy

Interventions

DIAGNOSTIC_TEST

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)

Sponsors & Collaborators

  • Centre Hospital Regional Universitaire de Limoges

    collaborator OTHER
  • Internist.Ro

    lead OTHER

Principal Investigators

  • Adrian Purcarea MD · Transylvania Univeristy, Faculty of Medicine, Brasov, Romania

  • Silvia Sovaila MD · Transylvania Univeristy, Faculty of Medicine, Brasov, Romania

  • Remy Bouquet MD · Gueret Hospital, Creuse, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06876545 on ClinicalTrials.gov