Malnutrition Clinical Trial
— MAL-EDOfficial title:
Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
Malnutrition is considered one of the most prevalent risk factors for morbidity and
mortality in children under five. An estimated 20% of children in the developing world are
malnourished [1] and poor nutrition is linked to more than half of all child deaths
worldwide [2]. Malnutrition in early childhood may lead to cognitive and physical deficits
and may cause similar deficits in future generations as malnourished mothers give birth to
low birth weight children [3]. In addition, malnutrition increases susceptibility and
incidence of infections and is associated with diminished response to vaccines.
The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that
alter gut function and impair children's nutrition, growth and development to help develop
new intervention strategies that can break the vicious enteric infection-malnutrition cycle
and reduce its global burden.
The overall objective of the MAL-ED Project is to quantify the associations of specific
enteric pathogens, measures of physical and mental development, micronutrient malnutrition,
gut function biomarkers, the gut microbiome, and immune responses in very young children in
resource-limited settings across eight sites that vary by culture, economics, geography, and
climate.
The central hypothesis of the MAL-ED Project is that infection (and co-infection) with
specific enteropathogens leads to impaired growth and development and to diminished immune
response to orally administered vaccines by causing intestinal inflammation and/or by
altering intestinal barrier and absorptive function. Data analyses will test for
associations between enteropathogen infections and growth/development to help illuminate:
- which micro-organisms or mixed infections are most frequently associated with growth
faltering and poor development; and
- at what age specific infections cause the most disruption to growth and development and
impair immune response.
Status | Active, not recruiting |
Enrollment | 1796 |
Est. completion date | April 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 17 Days |
Eligibility |
Inclusion Criteria: - Less than 17 days old. Exclusion Criteria: - Mother is less than 16 years of age. - Mother has another child inthe MAL-ED study. - Pregnancy resulted in multiple birth (e.g., twins). - Child has a severe disease requiring hospitalization for something other than for a typical healthy birth. - Child has a severe or chronic condition diagnosed by a medical doctor (e.g., neonatal disease, renal disease, chronic heart failure, liver disease, cystic fibrosis, congenital conditions). - Child has enteropathies diagnosed by medical doctor. - Mother is living and unable to provide informed consent. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrheal Disease Research, Bangladesh | Dhaka | |
Brazil | Universidade Federal do Ceará | Fortaleza | |
India | Christian Medical College | Vellore | |
Nepal | Institute of Medicine | Kathmandu | |
Pakistan | Aga Khan University | Karachi | |
Peru | JHSPH Satellite Laboratory | Iquitos | |
South Africa | University of Venda | Limpopo | |
Tanzania | Haydom Lutheran Hospital | Haydom |
Lead Sponsor | Collaborator |
---|---|
Foundation for the National Institutes of Health | Aga Khan University, Christian Medical College, Vellore, India, Henry M. Jackson Foundation for the Advancement of Military Medicine, Johns Hopkins University, National Institutes of Health, Fogarty International Center, Penn State University, University of Virginia |
Bangladesh, Brazil, India, Nepal, Pakistan, Peru, South Africa, Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diarrhea | All diarrheal samples are analyzed for the presence of bacterial, viral, and parasitic pathogens. Normal stool is collected monthly and analyzed for the same list of 57 different pathogens. | Each diarrheal episode willbe recorded for up to 24 months of age. | No |
Primary | Anthropometry | Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth. | Anthropomentry will be recorded each month for up to 24 months of age. | No |
Primary | Cognitive development | A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices. | Cognitive development will be recorded at 6 months of age. | No |
Primary | Vaccine response | Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines. | Vaccine response will be recorded at 7 months of age. | No |
Primary | Cognitive development | A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices. | Cognitive development will be recorded at 8 months of age. | No |
Primary | Cognitive development | A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices. | Cognitive development will be recorded at 15 months of age. | No |
Primary | Vaccine response | Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines. | Vaccine response will be recorded at 15 months of age. | No |
Primary | Cognitive development | A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices. | Cognitive development will be recorded 24 months of age. | No |
Primary | Vaccine response | Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines. | Vaccine response will be recorded at 24 months of age. | No |
Secondary | Gut inflammation | Stool biomarkers will be evaluated to detect gut and systemic inflammation. | Gut inflammation will be recorded each month for up to 24 months of age. | No |
Secondary | Gut integrity | Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test. | Gut integritywill be recorded at at 3 months of age. | No |
Secondary | Gut integrity | Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test. | Gut integritywill be recorded at at 6 months of age. | No |
Secondary | Gut integrity | Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test. | Gut integritywill be recorded at at 9 months of age. | No |
Secondary | Gut integrity | Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test. | Gut integritywill be recorded at at 15 months of age. | No |
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