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Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

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ClinicalTrials.gov Identifier: NCT03467022
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Battistelli, SCP Battistelli

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.


Condition or disease Intervention/treatment
Alcoholics Drug: Vitamin C

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.


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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy: A STROBE Compliant Study
Actual Study Start Date : January 2, 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C


Intervention Details:
  • Drug: Vitamin C
    Patients depleted or deficient in vitamin C by blood test were supplemented orally in vitamin C 1 gram per day for three months
    Other Name: Ascorbic acid


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).


Biospecimen Retention:   Samples Without DNA

Measurement of vitamin C ail be performed by high-pressure liquid chromatography (Cerba Laboratory, F-Cergy Pontoise).

Results are expressed in micromol per liter (µmol/L) with a normal range from 26,4 to 84,0µmol/L. These measures are in correlation with those quoted by O.Frain et al concerning healthy French men and women (5 to 15 mg/L equal to 28,4 -85,5µmol/L). According to Johnston's criteria, plasma vitamin C level lower than 11,4µmol/L (2mg/L) will be considered as vitamin C deficiency, lower than 28,4µmol/L (5 mg/L) as vitamin C depletion. The lower limit of quantification is 3µmol/L (< 0,5 mg /L); the patient is considered biologically as having scurvy or at high risk for development of scurvy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467022


Sponsors and Collaborators
SCP Battistelli
Investigators
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Principal Investigator: Daniel Battistelli, MD Nouvelle Clinique des Trois Frontieres Saint-Louis

Additional Information:
Publications:
Crandon JH, Lund CC, Dill DB. Experimental human scurvy. N Engl J Med 1940; 223:353-69

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Responsible Party: Daniel Battistelli, Director, SCP Battistelli
ClinicalTrials.gov Identifier: NCT03467022     History of Changes
Other Study ID Numbers: SCPBattistelli
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Laboratory vitamin C results which will be deidentified Anonymous data displayed in an Excel table
Time Frame: Data are available immediately and till end 2019
Access Criteria: Researchers interested in alcoholism combined with nutrition

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Battistelli, SCP Battistelli:
alcohol withdrawal
scurvy
vitamin C
tiredness
Additional relevant MeSH terms:
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Scurvy
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Ascorbic Acid Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Ascorbic Acid
Ethanol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents