Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy

NCT03467022 | Completed

• 1 other identifier: SCPBattistelli
• Study Type: observational
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholics

Keywords

alcohol withdrawal; scurvy; vitamin C; tiredness

Outcome Measures

Primary Outcomes (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

  23 months (beginning till end of the recruitment)

Secondary Outcomes (1)

• Correlation between plasma vitamin C and latent scurvy symptoms

  23 months (beginning till end of the recruitment)

Other Outcomes (1)

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

  3 to 4 months for each patient

Interventions

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

Also known as: Ascorbic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Confusion or alcoholic coma.

Sponsors & Collaborators

• SCP Battistelli: lead

Related Publications (10)

• 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.

  PMID: 9710847 BACKGROUND

• 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.

  PMID: 7814238 BACKGROUND

• 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.

  PMID: 12627180 BACKGROUND

• 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.

  PMID: 29382002 BACKGROUND

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

  PMID: 8990238 BACKGROUND

• 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.

  PMID: 14614974 BACKGROUND

• 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.

  PMID: 28771190 BACKGROUND

• 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.

  PMID: 11965507 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23446899 BACKGROUND

Related Links

• World Health Organization: Signs and symptoms; Classic scurvy. In: Scurvy and its prevention and control in major emergencies (1999) p 4

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.

MeSH Terms

Conditions

Scurvy; Fatigue

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Daniel Battistelli, MD

  Nouvelle Clinique des Trois Frontieres Saint-Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: March 15, 2018
• Study Start: January 2, 2014
• Primary Completion: November 30, 2016
• Study Completion: March 30, 2017
• Last Updated: March 26, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data are available immediately and till end 2019
• Access Criteria: Researchers interested in alcoholism combined with nutrition