AzTrials
AzTrials

AlcoholicsNCT03467022

Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

An observational study of Alcoholics, run by SCP Battistelli.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholics
What is being tested?
Vitamin C
Type of treatment
Pill or oral medicine
How many people
47 participants
Where
No sites listed yet
Study dates
2 Jan 2014to 30 Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Confusion or alcoholic coma.

About this study

Official title: 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.

Read the 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.

Conditions
Alcoholics
Being tested
Vitamin C
Keywords
alcohol withdrawal, scurvy, vitamin C, tiredness
Medical subject headings
Scurvy, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDrug

    Also called Ascorbic acid

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma vitamin C concentration in alcoholic withdrawal patients

    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

    Measured: 23 months (beginning till end of the recruitment)

Secondary outcomes (1)

  1. Correlation between plasma vitamin C and latent scurvy symptoms

    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".

    Measured: 23 months (beginning till end of the recruitment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start2 Jan 2014
  3. Primary completion30 Nov 2016
  4. Study completion30 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03467022
Sponsor's protocol ID
SCPBattistelli
Status last verified
Mar 2018
First submitted
18 Jan 2018
Last updated
26 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Laboratory vitamin C results which will be deidentified Anonymous data displayed in an Excel table

Publications

  • Johnston CS, Thompson LL. Vitamin C status of an outpatient population. J Am Coll Nutr. 1998 Aug;17(4):366-70. doi: 10.1080/07315724.1998.10718777.

    PubMed 9710847

  • Hercberg S, Preziosi P, Galan P, Devanlay M, Keller H, Bourgeois C, Potier de Courcy G, Cherouvrier F. Vitamin status of a healthy French population: dietary intakes and biochemical markers. Int J Vitam Nutr Res. 1994;64(3):220-32.

    PubMed 7814238

  • Bergheim I, Parlesak A, Dierks C, Bode JC, Bode C. Nutritional deficiencies in German middle-class male alcohol consumers: relation to dietary intake and severity of liver disease. Eur J Clin Nutr. 2003 Mar;57(3):431-8. doi: 10.1038/sj.ejcn.1601557.

    PubMed 12627180

  • Lux-Battistelli C, Battistelli D. Latent scurvy with tiredness and leg pain in alcoholics: An underestimated disease three case reports. Medicine (Baltimore). 2017 Nov;96(47):e8861. doi: 10.1097/MD.0000000000008861.

    PubMed 29382002

  • Lee W, Roberts SM, Labbe RF. Ascorbic acid determination with an automated enzymatic procedure. Clin Chem. 1997 Jan;43(1):154-7.

    PubMed 8990238

  • Fain O, Paries J, Jacquart B, Le Moel G, Kettaneh A, Stirnemann J, Heron C, Sitbon M, Taleb C, Letellier E, Betari B, Gattegno L, Thomas M. Hypovitaminosis C in hospitalized patients. Eur J Intern Med. 2003 Nov;14(7):419-425. doi: 10.1016/j.ejim.2003.08.006.

    PubMed 14614974

  • Pearson JF, Pullar JM, Wilson R, Spittlehouse JK, Vissers MCM, Skidmore PML, Willis J, Cameron VA, Carr AC. Vitamin C Status Correlates with Markers of Metabolic and Cognitive Health in 50-Year-Olds: Findings of the CHALICE Cohort Study. Nutrients. 2017 Aug 3;9(8):831. doi: 10.3390/nu9080831.

    PubMed 28771190

  • Malmauret L, Leblanc J, Cuvelier I, Verger P. Dietary intakes and vitamin status of a sample of homeless people in Paris. Eur J Clin Nutr. 2002 Apr;56(4):313-20. doi: 10.1038/sj.ejcn.1601312.

    PubMed 11965507

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

  • Carr AC, Bozonet SM, Pullar JM, Simcock JW, Vissers MC. Human skeletal muscle ascorbate is highly responsive to changes in vitamin C intake and plasma concentrations. Am J Clin Nutr. 2013 Apr;97(4):800-7. doi: 10.3945/ajcn.112.053207. Epub 2013 Feb 27.

    PubMed 23446899

Questions about this trial

What is this clinical trial studying?

An observational study of Alcoholics, run by SCP Battistelli.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma vitamin C concentration in alcoholic withdrawal patients (time frame: 23 months (beginning till end of the recruitment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467022, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in