Malnutrition Clinical Trial
— ELICITOfficial title:
Early Life Interventions for Childhood Growth and Development In Tanzania
Verified date | April 2021 |
Source | Haydom Lutheran Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.
Status | Completed |
Enrollment | 1188 |
Est. completion date | March 26, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Days |
Eligibility | Inclusion Criteria: 1. Maternal age =18 2. Infant = 14 days Exclusion Criteria: 1. Maternal inability to adhere to protocol 2. Multiple gestation 3. Severe illness (significant birth defect, hospitalization, severe neonatal illness) 4. Birth weight <1500 g 5. Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment). |
Country | Name | City | State |
---|---|---|---|
Tanzania | Haydom Lutheran Hospital | Haydom | Manyara |
Lead Sponsor | Collaborator |
---|---|
Haydom Lutheran Hospital | Bill and Melinda Gates Foundation, University of Virginia |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Height-for-age z-score (HAZ) at 18 months | 18 months | ||
Secondary | Weight-for-age z-score (WAZ) at 18 months | 18 months | ||
Secondary | Head circumference-for-age z-score (HCAZ) at 18 months | 18 months | ||
Secondary | Stunting | HAZ <-2 | 18 months | |
Secondary | All cause mortality | 0-18 months | ||
Secondary | Hospitalization | 0-18 months | ||
Secondary | Childhood illness | Incidence of diarrhea, lower respiratory infection and febrile illness | 0-18 months | |
Secondary | Anemia | Moderate to severe anemia by WHO definition for age and altitude | 12 and 18 months | |
Secondary | Enteropathogen burden | 6, 6.5, 12, 12.5, 18 months | ||
Secondary | Microbiota composition | Composition of intestinal microbiome | 6, 6.5, 12, 18 months | |
Secondary | Stool myeloperoxidase concentration | Stool myeloperoxidase ELISA | 6, 12, 18 months | |
Secondary | C-reactive protein concentration in serum | High-sensitivity CRP concentration | 12 and 18 months | |
Secondary | Insulin-like growth factor 1 concentration in serum | 12 and 18 months | ||
Secondary | Collagen X concentration in serum | 12 and 18 months | ||
Secondary | Tryptophan-kynurenine ratio | Ratio of tryptophan concentration to kynurenine concentration in metabolomic testing | 12 and 18 months | |
Secondary | Niacin and nicotinamide metabolite concentration | Concentration of downstream metabolites of niacin and nicotinamide as tested by metabolomic analysis | 6, 12, 18 months | |
Secondary | Small intestinal bacterial overgrowth | Prevalence of SIBO as tested via exhaled hydrogen | 6, 12 and 18 months | |
Secondary | Malawi Developmental Assessment Tool score | The MDAT is a measure of child cognitive development | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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