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

Diarrhea Clinical Trial

— VITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328037
• Other study ID #: 2020-063
• Secondary ID: ID-RCB number :
• Status: Completed
• Start date: April 25, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Diarrhea
• Infantile
• Scurvy

Intervention

Diagnostic Test:
• Blood sample collection
Blood sample collection for dosage of vitamin C

Locations

Country	Name	City	State
Central African Republic	Complexe Pédiatrique	Bangui
France	Hopital Necker	Paris
New Caledonia	Centre Hospitalier Territorial Gaston Bourret	Nouméa

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	Institut Cochin, University of Copenhagen

Countries where clinical trial is conducted

Central African Republic,  France,  New Caledonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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