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

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.

Study Overview

• Status: Recruiting
• Conditions: Diarrhea; Infantile
• Intervention / Treatment: Diagnostic test: Blood sample collection

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.

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Muriel Vray, PhD; Phone Number: 0033 1 40 61 39 58; Email: muriel.vray@pasteur.fr
• Study Contact Backup: Name: Benoit S Marteyn, PhD; Phone Number: 0033 1 40 61 38 94; Email: marteyn@pasteur.fr

Study Locations

• Central African Republic
  • Bangui, Central African Republic
    • Recruiting
    • Complexe Pédiatrique
    • Contact: Jean-Chrysotome Gody, MD, PhD
• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker
    • Contact: Thomas Blanc, MD, PhD
• New Caledonia
  • Nouméa, New Caledonia
    • Not yet recruiting
    • Centre Hospitalier Territorial Gaston Bourret
    • Contact: Emilie Huguon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Blood sample collection for dosage of vitamin C
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; Blood sample collection for dosage of vitamin C
Controls; Children without fever or signs of infection or ongoing diarrhea	Diagnostic test: Blood sample collection; Blood sample collection for dosage of vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: University of Copenhagen; Institut Cochin
• Investigators: Principal Investigator: Alexandre Manirakiza, MD, PhD, Institut Pasteur de Bangui, Centrafrican Republic; Principal Investigator: Thomas Blanc, MD, PhD, Hopital Necker Paris, France; Principal Investigator: DJean-Chrysostome Gody, MD, PhD, Complexe Pédiatrique de Bangui, Centrafrican Republic

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Diarrhea; Children; Vitamin C
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Hemorrhagic Disorders; Hemostatic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Diarrhea; Scurvy; Ascorbic Acid Deficiency
• Other Study ID Numbers: 2020-063; ID-RCB number : 2021-A00632-39 (Other Identifier: French national registration number of the study)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No