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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB number : 2021-A00632-39 | Other Identifier | French national registration number of the study |
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| Name | Class |
|---|---|
| Institut Cochin | OTHER |
| University of Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Chronic diarrhea cases | Children with chronic diarrhea defined as 3 or more loose or liquid stools per day for at least 4 weeks |
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| Controls | Children without fever or signs of infection or ongoing diarrhea |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Diagnostic Test | Blood sample collection for dosage of vitamin C |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Controls :
Inclusion Criteria:
Exclusion criteria :
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 :
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 :
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Manirakiza, MD, PhD | Institut Pasteur de Bangui, Centrafrican Republic | Principal Investigator |
| Thomas Blanc, MD, PhD | Hopital Necker Paris, France | Principal Investigator |
| Jean-Chrysostome Gody, MD, PhD | Complexe Pédiatrique de Bangui, Centrafrican Republic | Principal Investigator |
| Emilie Huguon, MD | Centre Hospitalier Térritorial Gaston Bourret, New Caledonia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexe Pédiatrique | Bangui | Central African Republic | ||||
| Hopital Necker |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Paris |
| 75015 |
| France |
| Centre Hospitalier Territorial Gaston Bourret | Noumea | New Caledonia |