Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-03-09 @ 4:02 PM
Study NCT ID:
NCT03268902
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Life Interventions for Childhood Growth and Development In Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}, {'id': 'D009536', 'term': 'Niacinamide'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-05', 'size': 615398, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-05T02:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both participants and investigators will be blinded to the treatments allocated to each participant. The members of the DSMB will also be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Each intervention will be assigned independently. Intervention domains will be randomized separately on an individual basis. This will provide 4 different combinations of interventions: 1). Nicotinamide, azithromycin and nitazoxanide 2). Azithromycin and nitazoxanide 3). Nicotinamide only 4). No active treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height-for-age z-score (HAZ) at 18 months', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Weight-for-age z-score (WAZ) at 18 months', 'timeFrame': '18 months'}, {'measure': 'Head circumference-for-age z-score (HCAZ) at 18 months', 'timeFrame': '18 months'}, {'measure': 'Stunting', 'timeFrame': '18 months', 'description': 'HAZ \\<-2'}, {'measure': 'All cause mortality', 'timeFrame': '0-18 months'}, {'measure': 'Hospitalization', 'timeFrame': '0-18 months'}, {'measure': 'Childhood illness', 'timeFrame': '0-18 months', 'description': 'Incidence of diarrhea, lower respiratory infection and febrile illness'}, {'measure': 'Anemia', 'timeFrame': '12 and 18 months', 'description': 'Moderate to severe anemia by WHO definition for age and altitude'}, {'measure': 'Enteropathogen burden', 'timeFrame': '6, 6.5, 12, 12.5, 18 months'}, {'measure': 'Microbiota composition', 'timeFrame': '6, 6.5, 12, 18 months', 'description': 'Composition of intestinal microbiome'}, {'measure': 'Stool myeloperoxidase concentration', 'timeFrame': '6, 12, 18 months', 'description': 'Stool myeloperoxidase ELISA'}, {'measure': 'C-reactive protein concentration in serum', 'timeFrame': '12 and 18 months', 'description': 'High-sensitivity CRP concentration'}, {'measure': 'Insulin-like growth factor 1 concentration in serum', 'timeFrame': '12 and 18 months'}, {'measure': 'Collagen X concentration in serum', 'timeFrame': '12 and 18 months'}, {'measure': 'Tryptophan-kynurenine ratio', 'timeFrame': '12 and 18 months', 'description': 'Ratio of tryptophan concentration to kynurenine concentration in metabolomic testing'}, {'measure': 'Niacin and nicotinamide metabolite concentration', 'timeFrame': '6, 12, 18 months', 'description': 'Concentration of downstream metabolites of niacin and nicotinamide as tested by metabolomic analysis'}, {'measure': 'Small intestinal bacterial overgrowth', 'timeFrame': '6, 12 and 18 months', 'description': 'Prevalence of SIBO as tested via exhaled hydrogen'}, {'measure': 'Malawi Developmental Assessment Tool score', 'timeFrame': '18 months', 'description': 'The MDAT is a measure of child cognitive development'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Stunting', 'Cognitive Development', 'Enteric Pathogens']}, 'referencesModule': {'references': [{'pmid': '41232946', 'type': 'DERIVED', 'citation': 'DeBoer MD, Elwood SE, Guga G, Jatosh S, Scharf RJ, Liu J, Rogawski McQuade ET, Mduma ER, Houpt E, Platts-Mills JA. Enteric pathogen carriage in early childhood is associated with elevated CRP, lower IGF-1 and linear growth deficits: the ELICIT study in rural Tanzania. BMJ Glob Health. 2025 Nov 12;10(11):e018454. doi: 10.1136/bmjgh-2024-018454.'}, {'pmid': '39032770', 'type': 'DERIVED', 'citation': 'Parpia T, Elwood S, Rogawski McQuade ET, Svensen E, Wanjuhi A, Jatosh S, Bayo E, Hhando E, Houpt ER, Mduma E, DeBoer MD, Scharf RJ, Platts-Mills JA. Growth and Cognitive Development in Tanzanian Children are Associated with Timing of Birth in Relation to Seasonal Malnutrition. J Pediatr. 2024 Dec;275:114202. doi: 10.1016/j.jpeds.2024.114202. Epub 2024 Jul 19.'}, {'pmid': '36963502', 'type': 'DERIVED', 'citation': 'DeBoer MD, Elwood SE, Platts-Mills JA, McDermid JM, Scharf RJ, Rogawski McQuade ET, Jatosh S, Houpt ER, Mduma E. Association of Circulating Biomarkers with Growth and Cognitive Development in Rural Tanzania: A Secondary Analysis of the Early Life Interventions in Childhood Growth and Development In Tanzania (ELICIT) Study. J Nutr. 2023 May;153(5):1453-1460. doi: 10.1016/j.tjnut.2023.03.020. Epub 2023 Mar 22.'}, {'pmid': '34582462', 'type': 'DERIVED', 'citation': 'DeBoer MD, Platts-Mills JA, Elwood SE, Scharf RJ, McDermid JM, Wanjuhi AW, Jatosh S, Katengu S, Parpia TC, Rogawski McQuade ET, Gratz J, Svensen E, Swann JR, Donowitz JR, Mdoe P, Kivuyo S, Houpt ER, Mduma E. Effect of scheduled antimicrobial and nicotinamide treatment on linear growth in children in rural Tanzania: A factorial randomized, double-blind, placebo-controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003617. doi: 10.1371/journal.pmed.1003617. eCollection 2021 Sep.'}, {'pmid': '29982218', 'type': 'DERIVED', 'citation': 'DeBoer MD, Platts-Mills JA, Scharf RJ, McDermid JM, Wanjuhi AW, Gratz J, Svensen E, Swann JR, Donowitz JR, Jatosh S, Houpt ER, Mduma E. Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT): a protocol for a randomised factorial, double-blind, placebo-controlled trial of azithromycin, nitazoxanide and nicotinamide. BMJ Open. 2018 Jul 7;8(7):e021817. doi: 10.1136/bmjopen-2018-021817.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.', 'detailedDescription': 'Children living in rural sub-Saharan Africa experience massive challenges to child thriving, with poor linear growth and delays in child development. In a cohort of 211 children living in the rural Haydom area of Tanzania (participating in the Interactions of Malnutrition \\& Enteric Infections: Consequences for Child Health and Development "MAL-ED" Study), 70.6% had stunted growth at 18 months. This rate of moderate and severe stunting (length-for-age z-score \\[HAZ\\] \\<-2 standard deviations) was the highest of the 8 study sites in MAL-ED.\n\nThis enormous deficit is likely associated with high rates of enteric infections with Campylobacter, E. coli pathotypes, Cryptosporidium, and Giardia, organisms susceptible to azithromycin and/or nitazoxanide. Infections such as these occur frequently in developing areas and are often associated with environmental enteropathy, including ongoing enteric inflammation and loss of enterocyte integrity, leading to possible bacterial translocation and poorer absorption of ingested nutrients. The consequences of these infections, enteric dysfunction and poor nutrient absorption frequently include growth stunting, learning delays, and an overall loss of human capital.\n\nEmerging evidence suggests a potential role for the tryptophan-niacin pathway (including the end-product nicotinamide, an isoform of vitamin B3) in decreasing mucosal inflammation and affecting enteral microbiota. At the Tanzania site of MAL-ED, serum levels of tryptophan were related to subsequent linear growth, further suggesting importance of the tryptophan-niacin pathway. What is not clear is whether early childhood growth and development could be improved by targeting enteric infection and the tryptophan-niacin pathway by 1) delivering antibiotics against specific bacteria and/or 2) providing vitamin B3 as nicotinamide/niacinamide.\n\nThe main analysis will be intention-to-treat but a secondary analysis will be per protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Maternal age ≥18\n2. Infant ≤ 14 days\n\nExclusion Criteria:\n\n1. Maternal inability to adhere to protocol\n2. Multiple gestation\n3. Severe illness (significant birth defect, hospitalization, severe neonatal illness)\n4. Birth weight \\<1500 g\n5. Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).'}, 'identificationModule': {'nctId': 'NCT03268902', 'acronym': 'ELICIT', 'briefTitle': 'Early Life Interventions for Childhood Growth and Development In Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Haydom Lutheran Hospital'}, 'officialTitle': 'Early Life Interventions for Childhood Growth and Development In Tanzania', 'orgStudyIdInfo': {'id': '19465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinamide and Antimicrobials', 'description': 'Nicotinamide Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension', 'interventionNames': ['Drug: Azithromycin Oral Liquid Product', 'Drug: Nitazoxanide Oral Suspension', 'Dietary Supplement: Nicotinamide']}, {'type': 'EXPERIMENTAL', 'label': 'Antimicrobials only', 'description': 'Placebo Azithromycin Oral Liquid Product Nitazoxanide Oral Suspension', 'interventionNames': ['Drug: Azithromycin Oral Liquid Product', 'Drug: Nitazoxanide Oral Suspension', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotinamide only', 'description': 'Nicotinamide Placebo Placebo', 'interventionNames': ['Dietary Supplement: Nicotinamide', 'Drug: Placebos']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No active treatment', 'description': 'Placebo Placebo Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Azithromycin Oral Liquid Product', 'type': 'DRUG', 'otherNames': ['Throza DPS'], 'description': 'Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months', 'armGroupLabels': ['Antimicrobials only', 'Nicotinamide and Antimicrobials']}, {'name': 'Nitazoxanide Oral Suspension', 'type': 'DRUG', 'otherNames': ['Alinia'], 'description': 'Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months', 'armGroupLabels': ['Antimicrobials only', 'Nicotinamide and Antimicrobials']}, {'name': 'Nicotinamide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin B3'], 'description': 'Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.\n\nChildren in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age', 'armGroupLabels': ['Nicotinamide and Antimicrobials', 'Nicotinamide only']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.\n\nMothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.\n\nChildren in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age', 'armGroupLabels': ['Antimicrobials only', 'Nicotinamide only', 'No active treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haydom', 'state': 'Manyara Region', 'country': 'Tanzania', 'facility': 'Haydom Lutheran Hospital'}], 'overallOfficials': [{'name': 'Estomih Mduma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haydom Lutheran Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydom Lutheran Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}