Combined Package of Interventions for Environmental Enteropathy

The Washington University

Status: Completed

Conditions: Environmental Enteropathy

Treatments: Dietary Supplement: Multiple Micronutrient Supplement; Drug: Placebo; Dietary Supplement: Zinc; Drug: Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02253095

EE-zinc-alb-micronut

Details and patient eligibility

About

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

Enrollment: 253 patients

Sex: All

Ages: 12 to 35 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 2 patient groups, including a placebo group

Multiple Intervention Arm

Experimental group

Description:

single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients

Treatment:

Drug: Albendazole

Dietary Supplement: Zinc

Dietary Supplement: Multiple Micronutrient Supplement

Placebo

Placebo Comparator group

Description:

three placebos

Treatment:

Drug: Placebo