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NCT Number: NCT03467022

Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

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.

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Key information

Conditions

Alcoholics Ascorbic Acid Deficiency Avitaminosis Cardiovascular Diseases Deficiency Diseases Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Scurvy Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study aims to examine:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin C

Drug

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

Other names: Ascorbic acid

Primary outcomes

  1. Plasma vitamin C concentration in alcoholic withdrawal patients

    Time frame: 23 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 outcomes

  1. Correlation between plasma vitamin C and latent scurvy symptoms

    Time frame: 23 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 outcomes

  1. Questionnaire detailing the evolution of tiredness/purpura/gums involvement after supplementation with 1g/day of oral vitamin C for three months

    Time frame: 3 to 4 months for each patient

    Deficient 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).

Sponsors and collaborators

Lead sponsor

SCP Battistelli

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 15, 2018
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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