Combined Package of Interventions for Environmental Enteropathy

Washington University School of Medicine253 enrolled

Overview

Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

253

Conditions

Environmental Enteropathy

Interventions

AlbendazoleDRUG

ZincDIETARY_SUPPLEMENT

Multiple Micronutrient SupplementDIETARY_SUPPLEMENT

PlaceboDRUG

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * children residing in catchment area of Limela, Machinga District, Malawi * aged 12-35 months * youngest eligible child in each household Exclusion Criteria: * severe acute malnutrition * severe chronic illness * children unable to drink 20 mL of dual sugar solution * children in need of acute medical treatment for illness or injury at time of enrollment

Locations (1)

Limela Rural Site

Limela, Machinga Distric, Malawi

Outcomes

Primary Outcomes

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 12 weeks

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 24 weeks

Secondary Outcomes

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 12 weeks

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 24 weeks

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 12 weeks

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 24 weeks

Data from ClinicalTrials.gov

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