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

The Washington University

Status: Completed

Conditions: Enteropathy

Treatments: Drug: Albendazole; Drug: Placebo; Dietary Supplement: High-dose Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT01440608

MJM-zincalbendazole

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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225 participants in 3 patient groups, including a placebo group

Zinc therapy

Experimental group

Description:

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

Treatment:

Dietary Supplement: High-dose Zinc

Albendazole

Experimental group

Description:

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

Treatment:

Drug: Albendazole

Placebo

Placebo Comparator group

Description:

Placebo will be given for 14 days

Treatment:

Drug: Placebo