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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05328037
Acronym
VITAL
Enrollment
288
Registered
2022-04-14
Start date
2022-04-25
Completion date
2024-03-25
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Infantile

Keywords

Vitamin C, Diarrhea, Children

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.

Interventions

DIAGNOSTIC_TESTBlood sample collection

Blood sample collection for dosage of vitamin C

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY
Institut Cochin
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 60 Months
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma levels of vitamin C1 yearPlasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries

Secondary

MeasureTime frameDescription
Plasma levels of vitamin A, C and E1 yearPlasma 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

Countries

Central African Republic, France, New Caledonia

Contacts

PRINCIPAL_INVESTIGATORAlexandre Manirakiza, MD, PhD

Institut Pasteur de Bangui, Centrafrican Republic

PRINCIPAL_INVESTIGATORThomas Blanc, MD, PhD

Hopital Necker Paris, France

PRINCIPAL_INVESTIGATORJean-Chrysostome Gody, MD, PhD

Complexe Pédiatrique de Bangui, Centrafrican Republic

PRINCIPAL_INVESTIGATOREmilie Huguon, MD

Centre Hospitalier Térritorial Gaston Bourret, New Caledonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026