Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

March 22, 2018 updated by: Daniel Battistelli, SCP Battistelli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

47

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
23 months (beginning till end of the recruitment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
23 months (beginning till end of the recruitment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 to 4 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCP Battistelli

Investigators

  • Principal Investigator: Daniel Battistelli, MD, Nouvelle Clinique des Trois Frontieres Saint-Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2014

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCPBattistelli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Laboratory vitamin C results which will be deidentified Anonymous data displayed in an Excel table

IPD Sharing Time Frame

Data are available immediately and till end 2019

IPD Sharing Access Criteria

Researchers interested in alcoholism combined with nutrition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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