Diarrhea Clinical Trial
— VITALOfficial title:
Study on the Association Between Vitamin C Deficiency and Diarrhea in Children
Verified date | December 2023 |
Source | Institut Pasteur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 288 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Central African Republic | Complexe Pédiatrique | Bangui | |
France | Hopital Necker | Paris | |
New Caledonia | Centre Hospitalier Territorial Gaston Bourret | Nouméa |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur | Institut Cochin, University of Copenhagen |
Central African Republic, France, New Caledonia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06283784 -
Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
|
N/A | |
Recruiting |
NCT03851835 -
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
|
Phase 3 | |
Completed |
NCT04003181 -
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
|
N/A | |
Completed |
NCT03596827 -
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
|
N/A | |
Recruiting |
NCT05372068 -
Cement flooRs AnD chiLd hEalth (CRADLE)
|
N/A | |
Completed |
NCT03972618 -
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT05052489 -
Registry and Clinical Observation of Children With Diarrhoeal Disease
|
||
Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
Completed |
NCT02428647 -
Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT01968408 -
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
|
Phase 3 | |
Completed |
NCT01739231 -
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
|
Phase 1/Phase 2 | |
Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
Not yet recruiting |
NCT01382199 -
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
|
Phase 3 | |
Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT00760851 -
Yogurt Study in Children 2-4 Years Old Attending Daycare
|
Phase 3 |