Clinical trial NCT05328037: Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
Official title: Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Infantile
Keywords: Vitamin C
Diarrhea
Children
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Cochin
name: University of Copenhagen
First posted: 2022-04-14
Enrollment: 288
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is children aged 2 to 5 years in metropolitan France, Central African Republic, and South America.

Control subjects will be included in the hospital when they come for consultation for reasons other than diarrhea.

Children suffering from acute or chronic diarrhea will be included in the hospital during a consultation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma levels of vitamin C
timeFrame: 1 year
Secondary outcomes:
measure: Plasma levels of vitamin A, C and E
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangui
country: Central African Republic
facility: Complexe Pédiatrique
city: Paris
country: France
facility: Hopital Necker
city: Nouméa
country: New Caledonia
facility: Centre Hospitalier Territorial Gaston Bourret
Study officials:
affiliation: Institut Pasteur de Bangui, Centrafrican Republic
name: Alexandre Manirakiza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Necker Paris, France
name: Thomas Blanc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexe Pédiatrique de Bangui, Centrafrican Republic
name: DJean-Chrysostome Gody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: