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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-25

Study Completion Date

2024-03-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diarrhea Infantile

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Blood sample collection

Intervention Type DIAGNOSTIC_TEST

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

Blood sample collection

Intervention Type DIAGNOSTIC_TEST

Blood sample collection for dosage of vitamin C

Controls

Children without fever or signs of infection or ongoing diarrhea

Blood sample collection

Intervention Type DIAGNOSTIC_TEST

Blood sample collection for dosage of vitamin C

Interventions

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Blood sample collection

Blood sample collection for dosage of vitamin C

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

-Children suffering from chronic diarrhea defined by the emission of at least 3 soft or liquid stools per day for at least 4 weeks.

-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

* 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 :

* 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 :

* 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

Minimum Eligible Age

18 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes