Status:

COMPLETED

Early Life Interventions for Childhood Growth and Development In Tanzania

Lead Sponsor:

Haydom Lutheran Hospital

Collaborating Sponsors:

University of Virginia

Bill and Melinda Gates Foundation

Conditions:

Malnutrition

Stunting

Eligibility:

All Genders

Up to 14 years

Phase:

PHASE2

PHASE3

Brief Summary

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

Detailed Description

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 Ha...

Eligibility Criteria

Inclusion

  • Maternal age ≥18
  • Infant ≤ 14 days

Exclusion

  • Maternal inability to adhere to protocol
  • Multiple gestation
  • Severe illness (significant birth defect, hospitalization, severe neonatal illness)
  • Birth weight \<1500 g
  • Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).

Key Trial Info

Start Date :

September 5 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 26 2020

Estimated Enrollment :

1188 Patients enrolled

Trial Details

Trial ID

NCT03268902

Start Date

September 5 2017

End Date

March 26 2020

Last Update

May 10 2021

Active Locations (1)

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Haydom Lutheran Hospital

Haydom, Manyara Region, Tanzania