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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05328037
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
Institut Cochin
University of Copenhagen
Information provided by (Responsible Party):
Institut Pasteur

Study Description
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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.


Condition or disease Intervention/treatment
Diarrhea Infantile 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 Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
Actual Study Start Date : April 25, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Vitamin C

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma levels of vitamin C [ Time Frame: 1 year ]
    Plasma levels of vitamin C will be used to determine whether vitamin-deficiency may occurs in children living in developing countries


Secondary Outcome Measures :
  1. Plasma levels of vitamin A, C and E [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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.

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)

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328037


Contacts
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Contact: Muriel Vray, PhD 0033 1 40 61 39 58 muriel.vray@pasteur.fr
Contact: Benoit S Marteyn, PhD 0033 1 40 61 38 94 marteyn@pasteur.fr

Locations
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Central African Republic
Complexe Pédiatrique Recruiting
Bangui, Central African Republic
Contact: Jean-Chrysotome Gody, MD, PhD         
France
Hopital Necker Not yet recruiting
Paris, France, 75015
Contact: Thomas Blanc, MD, PhD         
Sponsors and Collaborators
Institut Pasteur
Institut Cochin
University of Copenhagen
Investigators
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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
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT05328037    
Other Study ID Numbers: 2020-063
ID-RCB number : 2021-A00632-39 ( Other Identifier: French national registration number of the study )
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Vitamin C
Diarrhea
Children
Additional relevant MeSH terms:
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Scurvy
Ascorbic Acid Deficiency
Diarrhea
Signs and Symptoms, Digestive
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases