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临床试验/NCT03467022
NCT03467022已完成不适用

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

SCP Battistelli0 个研究点目标入组 47 人开始时间: 2014年1月2日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
主要终点
Plasma vitamin C concentration in alcoholic withdrawal patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Confusion or alcoholic coma.

结局指标

主要结局

Plasma vitamin C concentration in alcoholic withdrawal patients

时间窗: 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

次要结局

  • Correlation between plasma vitamin C and latent scurvy symptoms(23 months (beginning till end of the recruitment))

研究者

发起方
SCP Battistelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Battistelli

Director

SCP Battistelli

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