Clinical trial NCT03467022: Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy
Official title: Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy: A STROBE Compliant Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholics
Keywords: alcohol withdrawal
scurvy
vitamin C
tiredness
Lead sponsor: SCP Battistelli
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 51 patients volunteered to alcohol withdrawal, 14 women at a mean age of 52+/-8 (extreme 38 to 62 years) (range 24) and 37 men at a mean age of 58 +/-12 (extreme 34 to 83) (range 49).

Three men refused the blood test and one didn't show up for the appointment. The mean age of the 33 remaining male patients was not impacted: mean age of 58 with quite the same SD (13) and the same range.

Therefore 47 patients were included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma vitamin C concentration in alcoholic withdrawal patients
timeFrame: 23 months (beginning till end of the recruitment)
Secondary outcomes:
measure: Correlation between plasma vitamin C and latent scurvy symptoms
timeFrame: 23 months (beginning till end of the recruitment)
Other outcomes:
measure: Questionnaire detailing the evolution of tiredness/purpura/gums involvement after supplementation with 1g/day of oral vitamin C for three months
timeFrame: 3 to 4 months for each patient
Locations:
Study officials:
affiliation: Nouvelle Clinique des Trois Frontieres Saint-Louis
name: Daniel Battistelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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