Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
- Conditions
- DiarrheaInfantile
- Registration Number
- NCT05328037
- Lead Sponsor
- Institut Pasteur
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 288
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma levels of vitamin C 1 year Plasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries
- Secondary Outcome Measures
Name Time Method Plasma levels of vitamin A, C and E 1 year 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
Trial Locations
- Locations (3)
Complexe Pédiatrique
🇨🇫Bangui, Central African Republic
Hopital Necker
🇫🇷Paris, France
Centre Hospitalier Territorial Gaston Bourret
🇳🇨Nouméa, New Caledonia
Complexe Pédiatrique🇨🇫Bangui, Central African Republic