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

NCT05328037 | Completed

• 2 other identifiers: 2020-063ID-RCB number : 2021-A00632-39
• Study Type: observational
• Target: 288
• Locations: 3 countries
• Sites: 3

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.

Conditions

Diarrhea; Infantile

Keywords

Vitamin C; Diarrhea; Children

Outcome Measures

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

  1 year

Secondary Outcomes (1)

• Plasma levels of vitamin A, C and E

  1 year

Study Arms (3)

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

Blood sample collection DIAGNOSTIC_TEST

Blood sample collection for dosage of vitamin C

Acute diarrhea cases; Chronic diarrhea cases; Controls

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• not suffering of diarrhea
• no fever
• no sign of infection

You may not qualify if:

• 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 :
• Children suffering from chronic diarrhea defined by the emission of at least 3 soft or liquid stools per day for at least 4 weeks.
• Suspected or diagnosed infectious diseases
• Known genetic diseases
• Known diseases that may interfere with iron and/or vitamin C metabolism
• Known inflammatory diseases

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Cochin: collaborator
• University of Copenhagen: collaborator

Study Sites (3)

Complexe Pédiatrique

Bangui, Central African Republic

Location

Hopital Necker

Paris, 75015, France

Location

Centre Hospitalier Territorial Gaston Bourret

Noumea, New Caledonia

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre Manirakiza, MD, PhD

  Institut Pasteur de Bangui, Centrafrican Republic

  PRINCIPAL INVESTIGATOR

• Thomas Blanc, MD, PhD

  Hopital Necker Paris, France

  PRINCIPAL INVESTIGATOR

• Jean-Chrysostome Gody, MD, PhD

  Complexe Pédiatrique de Bangui, Centrafrican Republic

  PRINCIPAL INVESTIGATOR

• Emilie Huguon, MD

  Centre Hospitalier Térritorial Gaston Bourret, New Caledonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: April 25, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); NE (1); CE (1)