CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,188 enrolled
Drug / intervention
Azithromycin Oral Liquid Product +3 moredrug
Likely dose
Azithromycin Oral Liquid Product 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03268902
NCT03268902Phase 3Completed
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Early Life Interventions for Childhood Growth and Development In Tanzania

Haydom Lutheran Hospital·interventional·Posted Aug 31, 2017·Updated May 10, 2021

In Brief

A Phase 3 clinical trial evaluating Azithromycin Oral Liquid Product, Nitazoxanide Oral Suspension, and 2 other interventions for Malnutrition and 3 related conditions. Completed, enrolled 1,188 participants across 1 site.

Detailed Summary

This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalnutrition, Stunting, Cognitive Development, Enteric Pathogens
CountriesTanzania
CollaboratorsUniversity of Virginia, Bill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartSep 5, 2017
Primary CompletionFeb 28, 2020
Study CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.8 years ago

Interventions

Azithromycin Oral Liquid Productdrug

Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months

Nitazoxanide Oral Suspensiondrug

Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months

Nicotinamidedietary

Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form. Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age

Placebosdrug

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. Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form. Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age