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CompletedNCT05328037VITALUpdated Feb 3, 2026

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

An observational study in Diarrhea and Infantile, sponsored by Institut Pasteur. Completed at 3 sites in 3 countries. Open to participants aged 18 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Institut Pasteur · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
288
Ages
18 Months to 60 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diarrhea
  • Infantile

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Keywords

  • Vitamin C
  • Diarrhea
  • Children
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 288 is above the median of 200 across 105 observational studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population is children aged 18 months to 5 years (60 months) 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.

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)
  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
288 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute diarrhea cases

    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

  • Chronic diarrhea cases

    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

  • Controls

    Children without fever or signs of infection or ongoing diarrhea

    Diagnostic Test: Blood sample collection

Interventions

  • Diagnostic testBlood sample collection

    Blood sample collection for dosage of vitamin C

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

3 sites
  • Complexe Pédiatrique
    Bangui, Central African Republic
  • Hopital Necker
    Paris, 75015, France
  • Centre Hospitalier Territorial Gaston Bourret
    Noumea, New Caledonia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05328037
Lead sponsor
Institut Pasteur
Collaborators
Institut Cochin, University of Copenhagen
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Apr 25, 2022
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Last update
Feb 3, 2026

Study contacts

Alexandre Manirakiza, MD, PhD
principal investigator · Institut Pasteur de Bangui, Centrafrican Republic
Thomas Blanc, MD, PhD
principal investigator · Hopital Necker Paris, France
Jean-Chrysostome Gody, MD, PhD
principal investigator · Complexe Pédiatrique de Bangui, Centrafrican Republic
Emilie Huguon, MD
principal investigator · Centre Hospitalier Térritorial Gaston Bourret, New Caledonia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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