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Clinical Trials/NCT06876545
NCT06876545Not yet recruitingNot Applicable

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

Internist.Ro1 site in 1 country150 target enrollmentStarted: April 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.

Study Overview

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.

Detailed Description

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:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Internist.Ro
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Purcarea Adrian

MD, PhD

Internist.Ro

Study Sites (1)

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