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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc therapy

High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days

Group Type EXPERIMENTAL

High-dose Zinc

Intervention Type DIETARY_SUPPLEMENT

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

Albendazole

Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

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

Placebo

Placebo will be given for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

High-dose Zinc

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 1-3 years of age
* Lives in study villages

Exclusion Criteria

* Unable to drink 100 mL of sugar water
* Demonstrating evidence of severe acute malnutrition, WHZ \< or = -3, presence of bi-pedal pitting edema
* Apparent need for acute medical treatment for an illness or injury
* Parent refusal to participate and return for 7-week follow-up

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes