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

NCT06876545 | Not Yet Recruiting

• 1 other identifier: A001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Scurvy, vitamin C defficiency, hospitalized

Outcome Measures

Primary Outcomes (1)

• 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: Vitamin C deficiency will be determined based on serum ascorbic acid levels measured through blood sampling. A deficient status is defined as a serum ascorbic acid concentration below the reference values established by the central laboratory (Cerba, Paris, France). Only 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.

Study Arms (2)

Historical control group

Control Group (Historical Cohort): Patients who underwent Vitamin C testing based on traditional clinical judgment, meaning testing was performed "as needed" at the discretion of the treating physician. No standardized criteria were applied for selecting patients for Vitamin C testing. Data will be collected from medical records retrospectively (prior to the introduction of a systematic screening approach).

Prospective Cohort

Active Group (Systematic Screening Cohort): Patients who underwent Vitamin C testing based on a predefined, rigorous suspicion framework (SFI - Scurvy Suspected upon Hemorrhagic Risk). Testing was systematically performed in patients with predefined hemorrhagic risk factors, including: Hematuria (macroscopic or detected via dipstick/microscopy). Ecchymoses (bruising). Petechiae. Epistaxis. Gastrointestinal bleeding (melena, hematemesis, positive fecal occult blood test). Cerebral hemorrhage. The selection for testing was systematic and protocol-driven, ensuring a more structured and standardized approach.

Diagnostic Test: systematical screening of at risk patients based on predefined hemorrhagic criteria

Interventions

systematical screening of at risk patients based on predefined hemorrhagic criteria DIAGNOSTIC_TEST

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)

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received Vitamin C supplementation within the month prior to testing. Incomplete or missing medical records regarding hemorrhagic manifestations or Vitamin C test results. Hemorrhagic events clearly attributable to anticoagulant or antiplatelet overdose, without other potential contributing factors. Blood samples processed more than 2 hours after collection, making Vitamin C levels unreliable.

You may qualify if:

• 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.

Sponsors & Collaborators

• Internist.Ro: lead
• Centre Hospital Regional Universitaire de Limoges: collaborator

Study Sites (1)

Gueret Hospital

Guéret, Creuse, 23000, France

Location

MeSH Terms

Conditions

Scurvy

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Ascorbic Acid Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Adrian Purcarea MD

  Transylvania Univeristy, Faculty of Medicine, Brasov, Romania

  STUDY DIRECTOR

• Silvia Sovaila MD

  Transylvania Univeristy, Faculty of Medicine, Brasov, Romania

  PRINCIPAL INVESTIGATOR

• Remy Bouquet MD

  Gueret Hospital, Creuse, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian PURCAREA MD

CONTACT

0040751141636; adrian.purcarea@internist.ro

Silvia Sovaila MD

CONTACT

0040753020253; sovaila.silvia@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 10years after study start
• Access Criteria: If justified by formal request or predefined protocol and after accord from the local Ethics Committee

Locations

FR (1)