Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
- Conditions
- DiarrheaInfantile
- Interventions
- Diagnostic Test: Blood sample collection
- 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
- Arm && Interventions
Group Intervention Description Controls Blood sample collection Children without fever or signs of infection or ongoing diarrhea Acute diarrhea cases Blood sample collection 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 Chronic diarrhea cases Blood sample collection Children with chronic diarrhea defined as 3 or more loose or liquid stools per day for at least 4 weeks
- 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