Alcohol Abuse or Alcohol Withdrawal: Risk of Latent Scurvy
NCT ID: NCT03467022
Last Updated: 2018-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
47 participants
OBSERVATIONAL
2014-01-02
2017-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
N-acetylcysteine in Alcohol Dependence
NCT00568087
Medication Development in Alcoholism: Acamprosate Versus Naltrexone
NCT00656630
Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption
NCT06840652
NIAAA Natural History Protocol
NCT02231840
Alcohol: Thiamine and or Magnesium 1
NCT03466528
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Each patient provided written consent to the study and agreed to pay himself the determination of the plasma ascorbic level.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SCP Battistelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Battistelli
Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Battistelli, MD
Role: PRINCIPAL_INVESTIGATOR
Nouvelle Clinique des Trois Frontieres Saint-Louis
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Lee W, Roberts SM, Labbe RF. Ascorbic acid determination with an automated enzymatic procedure. Clin Chem. 1997 Jan;43(1):154-7.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization: Signs and symptoms; Classic scurvy. In: Scurvy and its prevention and control in major emergencies (1999) p 4
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCPBattistelli
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.