DiarrheaVITALNCT05328037
Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
An observational study of Diarrhea and Infantile, run by Institut Pasteur at 3 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 monthsHealthy volunteers can take part
- What is being tested?
- Blood sample collection
- How many people
- 288 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Apr 2022to 25 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Central African Republic1 site
Complexe Pédiatrique
Bangui
New Caledonia1 site
Centre Hospitalier Territorial Gaston Bourret
Noumea
About this study
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.
Read the 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.
- Being tested
- Blood sample collection
- Keywords
- Vitamin C, Diarrhea, Children
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
Blood sample collection for dosage of vitamin C
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Blood sample collection | |
| Controls | Children without fever or signs of infection or ongoing diarrhea Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start25 Apr 2022
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Cochin, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Alexandre Manirakiza, MD, PhD, Principal investigator, Institut Pasteur de Bangui, Centrafrican RepublicThomas Blanc, MD, PhD, Principal investigator, Hopital Necker Paris, FranceJean-Chrysostome Gody, MD, PhD, Principal investigator, Complexe Pédiatrique de Bangui, Centrafrican RepublicEmilie Huguon, MD, Principal investigator, Centre Hospitalier Térritorial Gaston Bourret, New Caledonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328037
- Sponsor's protocol ID
- 2020-063
- Other IDs
- ID-RCB number : 2021-A00632-39
- Acronym
- VITAL
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
- ClinicalTrials.gov ID
- NCT05328037
- Acronym / sponsor ID
- VITAL / 2020-063
- Keywords
- Vitamin C, Diarrhea, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Cochin, University of Copenhagen
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute diarrhea cases | – | Diagnostic Test: Blood sample collectionChildren 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 |
| Chronic diarrhea cases | – | Diagnostic Test: Blood sample collectionChildren with chronic diarrhea defined as 3 or more loose or liquid stools per day for at least 4 weeks |
| Controls | – | Diagnostic Test: Blood sample collectionChildren without fever or signs of infection or ongoing diarrhea |
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (30 listed)
- Suspected or diagnosed infectious diseases
- Known genetic diseases
- Known diseases that may interfere with iron and/or vitamin C metabolism
- Known inflammatory diseases
- Malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection for dosage of vitamin C | Diagnostic test | Acute diarrhea cases, Chronic diarrhea cases, Controls |
Primary outcome
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
1 secondary outcome
Plasma levels of vitamin A, C and E
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Manirakiza, MD, PhD principal investigator
Institut Pasteur de Bangui, Centrafrican Republic
Thomas Blanc, MD, PhD principal investigator
Hopital Necker Paris, France
Jean-Chrysostome Gody, MD, PhD principal investigator
Complexe Pédiatrique de Bangui, Centrafrican Republic
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Infantile, run by Institut Pasteur at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Central African Republic, France, New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of vitamin C (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.