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Completed

NCT Number: NCT05328037

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

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.

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Key information

Age range

18 month–60 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Complexe Pédiatrique, Bangui, Central African Republic

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

Blood sample collection

Diagnostic Test

Blood sample collection for dosage of vitamin C

Primary outcomes

  1. Plasma levels of vitamin C

    Time frame: 1 year

    Plasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries

Secondary outcomes

  1. Plasma levels of vitamin A, C and E

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Institut Cochin
  • University of Copenhagen

Registry information

Acronym: VITAL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2022
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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