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

ConditionScurvy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInternist.Ro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • 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)

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Historical control group0 interventions
Group B: Prospective Cohort1 intervention

Trial outcomes

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.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Internist.Ro

Lead sponsor

Centre Hospital Regional Universitaire de Limoges

Collaborator

This trial is not recruiting at the moment. You can still explore other options: