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Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy

NCT01440608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2012-03-06

No results posted yet for this study

Summary

The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.

Conditions

  • Enteropathy

Interventions

DRUG

Albendazole

Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age

DRUG

Placebo

Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.

DIETARY_SUPPLEMENT

High-dose Zinc

Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs

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 NCT01440608 on ClinicalTrials.gov