drugset / Trial / NCT03268902
Early Life Interventions for Childhood Growth and Development In Tanzania
Phase 2/3
Completed
1188 enrolled
Haydom Lutheran Hospital
Bill and Melinda Gates Foundation · collabUniversity of Virginia · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.
Timeline
- Start
- 2017-09-05
- Primary completion
- 2020-02-28
- Completion
- 2020-03-26
Outcome
Missed primary endpoint
paper antimicrobial: -2.05 CI -2.13, -1.96, placebo: -2.05 CI -2.14, -1.97; mean difference: 0.01 CI -0.13, 0.11, p = 0.91 PMID 34582462 ↗
paper nicotinamide: -2.06 CI -2.13, -1.95, placebo: -2.04 CI -2.14, -1.98, mean difference 0.03 CI -0.15, 0.09, p = 0.66 PMID 34582462 ↗
Publications
- DeBoer MD, McDermid JM, Hampel D, Shahab-Ferdows S, Mazzoni G, Peerson JM, Elwood SE, Scharf RJ, Jatosh S, Platts-Mills JA, Mduma E, Allen LH. Human-milk vitamin B-3 (niacin and vitamer) concentrations: secondary analysis of a randomized, placebo-controlled trial of maternal nicotinamide supplementation in rural Tanzania. Am J Clin Nutr. 2026 Jun 17:101397. doi: 10.1016/j.ajcnut.2026.101397. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 20 mg/kg | Oral |
| Subject | Nicotinamide | Other / unclassified | 100 mg | Oral |
| Subject | Nicotinamide | Other / unclassified | 250 mg | Oral |
| Subject | Nitazoxanide | Other / unclassified | 100 mg | Oral |