Stunting Clinical Trial
— JiVitA-6Official title:
Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants
Verified date | December 2022 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.
Status | Completed |
Enrollment | 5283 |
Est. completion date | March 24, 2020 |
Est. primary completion date | March 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 6 Months |
Eligibility | Inclusion Criteria: - Born to women enrolled in ongoing community trial (NCT02909179) over a one-year period Exclusion Criteria: - Born to women not registered as part of the ongoing community trial (NCT02909179) |
Country | Name | City | State |
---|---|---|---|
Bangladesh | JiVitA Maternal and Child & Nutrition Research Site | Gaibandha |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
Arsenault JE, Brown KH. Dietary Protein Intake in Young Children in Selected Low-Income Countries Is Generally Adequate in Relation to Estimated Requirements for Healthy Children, Except When Complementary Food Intake Is Low. J Nutr. 2017 May;147(5):932-939. doi: 10.3945/jn.116.239657. Epub 2017 Feb 15. — View Citation
Lang D; MAL-ED Network Investigators. Opportunities to assess factors contributing to the development of the intestinal microbiota in infants living in developing countries. Microb Ecol Health Dis. 2015 May 29;26:28316. doi: 10.3402/mehd.v26.28316. eCollection 2015. — View Citation
MAL-ED Network Investigators. Relationship between growth and illness, enteropathogens and dietary intakes in the first 2 years of life: findings from the MAL-ED birth cohort study. BMJ Glob Health. 2017 Dec 28;2(4):e000370. doi: 10.1136/bmjgh-2017-000370. eCollection 2017. — View Citation
Uauy R. Keynote: rethinking protein. Food Nutr Bull. 2013 Jun;34(2):228-31. doi: 10.1177/156482651303400213. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length-for-age Z-score (LAZ) at 12 months of age | 12 months | ||
Secondary | Nutrient biomarkers | Serum essential, conditionally essential amino acids and choline (by metabolomic analysis); retinol and tocopherols (HPLC); vitamin B12 (microbiological assay); zinc (AAS); ferritin and thyroglobulin (ELISA) | 6 and 12 months | |
Secondary | Growth hormone and stress axes biomarkers | Serum insulin-like growth factor 1 (IGF-1), IGF binding protein 3, cortisol, by ELISA | 6 and 12 months | |
Secondary | Enteropathogen burden | Campylobacter, enterotoxigenic Escherichia coli (ETEC), enteroaggregative Escherichia coli (EAEC), enteropathogenic Escherichia coli (EPEC), Shigella and Cryptosporidium, by quantitative polymerase chain reaction (qPCR) | 6, 6.5, 9, 9.5, 12, 15, and 18 months | |
Secondary | Gut microbiota composition | Microbial diversity and abundance, by 16S ribosomal RNA sequencing | 6, 6.5, 9, 9.5, 12, 15, and 18 months | |
Secondary | Environmental enteric dysfunction biomarkers | Stool myeloperoxidase and intestinal fatty acid-binding protein concentrations and plasma Endogenous endotoxin-core antibody (EndoCAb), by ELISA | 6 and 12 months | |
Secondary | Inflammatory biomarkers | Plasma alpha-1 acid glycoprotein, C-reactive protein and interleukin-6, by ELISA; stool inflammatory cytokines, by ELISA | 6 and 12 months | |
Secondary | Bone biomarkers | Plasma collagen type X and N-Terminal Pro-C-Type Natriuretic Peptide (NT-ProCNP), by ELISA | 6 and 12 months | |
Secondary | Morbidity incidence | Incident diarrhea/dysentery or respiratory infection, based on weekly recalls | 6-12 months | |
Secondary | Body composition | Fat mass by bioelectrical impedence | 6, 9, 12, 15, and 18 months | |
Secondary | Antibiotic resistance | Resistance of commensal E. coli (stool) or S. pneumoniae (nasopharyngeal swab) to panel of antibiotics, by culture | 6, 9, 12, 15, and 18 months |
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