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Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy: A STROBE Compliant Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03467022
Enrollment
47
Registered
2018-03-15
Start date
2014-01-02
Completion date
2017-03-30
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholics

Keywords

alcohol withdrawal, scurvy, vitamin C, tiredness

Brief summary

Scurvy, or latent scurvy, may be underestimated in developed countries, but continue to be described, often as case report. Little is known about the prevalence of vitamin C deficiency in a specific population as withdrawal alcoholics and about his possible consequences, latent scurvy. In an observational study, the investigators will evaluate prospectively the prevalence of vitamin C deficiency in alcoholic withdrawal patients, its correlation with latent scurvy, mainly tiredness and weakness, and the evolution of the latter at three months after oral vitamin C supplementation.

Detailed description

This study aims to examine: 1. the level of plasma vitamin C for patients that volunteered for alcohol withdrawal. Measurement of vitamin C plasma level will be performed as soon as possible after the agreement as the discussion with the physician could lead to a change in dietary habits. It will be performed by high-pressure liquid chromatography (Cerba Laboratory, F-Cergy Pontoise) according to Lee et al. 2. the correlation between plasma vitamin C level and clinical signs of scurvy, especially signs of latent scurvy like tiredness, leg pain, gums involvement, previously loss of healthy teeth. These signs will be recorded in a structured questionnaire during the first consultation, before knowing the laboratory result patient. All patients who are smoking will perform systematic otorhinolaryngology examination in search of cancer. Other reasons for weakness will be searched by clinical anamneses, body examination, blood probe and abdominal ultrasound examination. 3. the decrease or disappearance of tiredness and/or purpura and/or gums involvement will be studied after vitamin C supplementation in patients whose vitamin C plasma determination is under normal levels and that don't have another explanation for their tiredness. Patients will be evaluated after receiving 1 g oral vitamin C for at least three months. Ethical considerations The study was approved by the institutional ethics committee of the clinic and was conducted in accordance with the principles of the Declaration of Helsinki. Informed consent was obtained before entry study and each participant agreed to pay for the plasma vitamin C determination. Dissemination findings Findings for the present study will be reported in manuscripts that will be submitted for publication to a leading medical or nutrition journal in a appropriate field (i.e.alcoholism, nutrition). In addition, findings will be presented as abstracts, posters and presentations at conferences.

Interventions

DRUGVitamin C

Patients depleted or deficient in vitamin C by blood test were supplemented orally in vitamin C 1 gram per day for three months

Sponsors

SCP Battistelli
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who volunteered for alcohol detoxification even if they had prior complications of excessive alcohol consumption. * Each patient provided written consent to the study and agreed to pay himself the determination of the plasma ascorbic level.

Exclusion criteria

* Confusion or alcoholic coma.

Design outcomes

Primary

MeasureTime frameDescription
Plasma vitamin C concentration in alcoholic withdrawal patients23 months (beginning till end of the recruitment)Plasma vitamin C determination will be performed as soon as possible after the consent of the patient. Measurement of vitamin C will be performed by high-pressure liquid chromatography (Cerba Laboratory, F-Cergy Pontoise) with a Roche Fara centrifugal analyzer

Secondary

MeasureTime frameDescription
Correlation between plasma vitamin C and latent scurvy symptoms23 months (beginning till end of the recruitment)Using Excel, we will apply a transformation to convert status of tiredness, skin symptoms and gum involvement/ loss of healthy teeth into binary variables.This is in order to provide a better graphical representation. One graph will be displayed per symptom. When it comes to the binary variables, 0 corresponds to absence of tiredness whereas 1 corresponds to presence of tiredness for the first graph; 0 corresponds to absence of purpura whereas 1 means presence of purpura for the second graph; 0 corresponds to absence of gums involvement or absence of loss of healthy teeth whereas 1 means presence of gums involvement or loss of healthy teeth.

Other

MeasureTime frameDescription
Questionnaire detailing the evolution of tiredness/purpura/gums involvement after supplementation with 1g/day of oral vitamin C for three months3 to 4 months for each patientDeficient or depleted patients will be supplemented with 1g/day of oral vitamin C for three months. When being examined after three months, the patients will be asked about the feeling of tiredness and the evolution of purpura and gums involvement will be investigated. Results will be expressed with binary variables (0 corresponds to a non-improvement state whereas 1 corresponds to an improvement state).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026