Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 3
- 主要终点
- Plasma levels of vitamin C
研究概览
简要总结
Diarrheal disease is the second leading cause of death in children under five, althought it is both preventable and treatable. The causative factors of diarrheal diseases vary a lot from region to region (bacteria, viruses, parasites). Diarrhea is one of the main causes of malnutrition in children under five years of age. Inversely, nutritional deficiency, particularly vitamin C deficiency, can be a risk factor for diarrhea.
The main objective of this study is to assess the impact of vitamin C deficiency on diarrheal infection in children aged 2 to 5 years in countries with a high diarrheal rate. This pilot case-control study will be conducted in metropolitan France, Africa and South America. This question will be addressed by comparing vitamin C levels in children with diarrhea, regardless of the infectious agent, to levels in age- and sex-matched controls.
详细描述
Diarrheal disease is the second leading cause of death in children under five, althought it is both preventable and treatable. The causative factors of diarrheal diseases vary a lot from region to region (bacteria, viruses, parasites). Diarrhea is one of the main causes of malnutrition in children under five years of age. Inversely, nutritional deficiency, particularly vitamin C deficiency, can be a risk factor for diarrhea.
The main objective of this study is to assess the impact of vitamin C deficiency on diarrheal infection in children aged 2 to 5 years in countries with a high diarrheal rate. This pilot case-control study will be conducted in metropolitan France, Africa and South America. This question will be addressed by comparing vitamin C levels in children with diarrhea, regardless of the infectious agent, to levels in age- and sex-matched controls.
The study aims at (i) determining whether vitamin-deficiency may occurs in children living in developing countries and at (ii) determining the plasma vitamin A, C and E concentrations in children suffering of diarrheal diseases.
A total of 360 children will participate to the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •not suffering of diarrhea
- •no sign of infection
排除标准
- •Suspected or diagnosed infectious diseases
- •Known genetic diseases
- •Known diseases that may interfere with iron and/or vitamin C metabolism
- •Known inflammatory diseases
- •Malnutrition
- •Positive malaria rapid diagnostic test (Africa)
- •Child currently being breastfed
- •Chronic diarrhea cases :
- •Inclusion Criteria:
- •Children suffering from chronic diarrhea defined by the emission of at least 3 soft or liquid stools per day for at least 4 weeks.
- •Exclusion criteria :
- •Suspected or diagnosed infectious diseases
- •Known genetic diseases
- •Known diseases that may interfere with iron and/or vitamin C metabolism
- •Known inflammatory diseases
- •Positive malaria rapid diagnostic test (Africa)
- •Antibiotic treatment prescribed within 10 days prior to sampling
- •Nutritional supplements in the three months prior to sampling
- •Vitamin C supplementation in the last 3 months prior to blood collection
- •Child currently being breastfed
- •Acute diarrhea cases :
- •Inclusion Criteria:
- •Children suffering from acute diarrhea defined as 3 or more loose or watery stools per day for at least 3 consecutive days and up to 10 consecutive days.
- •Exclusion criteria :
- •Malnutrition
- •Suspected or diagnosed infectious diseases
- •Known genetic diseases
- •Known diseases that may interfere with iron and/or vitamin C metabolism
- •Known inflammatory diseases
- •Positive malaria rapid diagnostic test (Africa)
- •Antibiotic treatment prescribed within 10 days prior to sampling
- •Nutritional supplements in the three months prior to sampling
- •Vitamin C supplementation in the last 3 months prior to blood collection
- •Child currently being breastfed
研究组 & 干预措施
Acute diarrhea cases
Children with acute diarrhea defined as at least 3 loose or watery stools per day for at least 3 consecutive days and up to 10 consecutive days
干预措施: Blood sample collection (Diagnostic Test)
Chronic diarrhea cases
Children with chronic diarrhea defined as 3 or more loose or liquid stools per day for at least 4 weeks
干预措施: Blood sample collection (Diagnostic Test)
Controls
Children without fever or signs of infection or ongoing diarrhea
干预措施: Blood sample collection (Diagnostic Test)
结局指标
主要结局
Plasma levels of vitamin C
时间窗: 1 year
Plasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries
次要结局
- Plasma levels of vitamin A, C and E(1 year)