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Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent

NCT00530374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2021-04-19

No results posted yet for this study

Summary

The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral Iron Supplement

Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

DIETARY_SUPPLEMENT

Placebo

Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

Sponsors & Collaborators

  • Bangladesh Rural Advancement Committee

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Stanley Zlotkin, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-01-31
Completion
2009-04-30

Countries

  • Bangladesh

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530374 on ClinicalTrials.gov