Early Life Interventions for Childhood Growth and Development In Tanzania

Summary

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

Conditions

• Malnutrition
• Stunting
• Cognitive Development
• Enteric Pathogens

Interventions

DRUG

Azithromycin Oral Liquid Product

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

DRUG

Nitazoxanide Oral Suspension

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

DIETARY_SUPPLEMENT

Nicotinamide

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

DRUG

Placebos

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

Sponsors & Collaborators

• University of Virginia

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Haydom Lutheran Hospital

  lead OTHER

Principal Investigators

• Estomih Mduma · Haydom Lutheran Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

0 Days

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-05

Primary Completion

2020-02-28

Completion

2020-03-26

FDA Drug

Yes

Countries

• Tanzania