Study on the Association Between Vitamin C Deficiency and Diarrhea in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Association Between Vitamin C Deficiency and Diarrhea in Children

Conditions
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Diarrhea, Infantile

Intervention / Treatment
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* Diagnostic Test: Blood sample collection


Participation Criteria
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Eligibility Criteria
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Controls : Inclusion Criteria: not suffering of diarrhea no fever no sign of infection 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 Malnutrition Diarrhea Fever Positive malaria rapid diagnostic test (Africa) 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 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute diarrhea cases<br>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 | Diagnostic Test: Blood sample collection<br>* Blood sample collection for dosage of vitamin C<br>|
| Chronic diarrhea cases<br>Children with chronic diarrhea defined as 3 or more loose or liquid stools per day for at least 4 weeks | Diagnostic Test: Blood sample collection<br>* Blood sample collection for dosage of vitamin C<br>|
| Controls<br>Children without fever or signs of infection or ongoing diarrhea | Diagnostic Test: Blood sample collection<br>* Blood sample collection for dosage of vitamin C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of vitamin C | Plasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of vitamin A, C and E | Plasma levels of vitamin A, C and E will be used to determine the plasma vitamin A, C and E concentrations in children suffering of diarrheal diseases | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, Diarrhea, Children