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NCT03467022 Clinical Trial

Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

Alcoholics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03467022
Other study ID # SCPBattistelli
Secondary ID
Status Completed
Phase
First received January 18, 2018
Last updated March 22, 2018
Start date January 2, 2014
Est. completion date March 30, 2017

Study information
Verified date March 2018
Source SCP Battistelli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date March 30, 2017
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
SCP Battistelli

References & Publications (10)

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. — View Citation

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. — View Citation

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

Fain O, Pariés J, Jacquart B, Le Moël G, Kettaneh A, Stirnemann J, Héron C, Sitbon M, Taleb C, Letellier E, Bétari B, Gattegno L, Thomas M. Hypovitaminosis C in hospitalized patients. Eur J Intern Med. 2003 Nov;14(7):419-425. — View Citation

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. — View Citation

Johnston CS, Thompson LL. Vitamin C status of an outpatient population. J Am Coll Nutr. 1998 Aug;17(4):366-70. — View Citation

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

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. — View Citation

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. — View Citation

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). pii: E831. doi: 10.3390/nu9080831. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Questionnaire detailing the evolution of tiredness/purpura/gums involvement after supplementation with 1g/day of oral vitamin C for three months 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
Primary 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		 23 months (beginning till end of the recruitment)
Secondary 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". 23 months (beginning till end of the recruitment)

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