Combined Package of Interventions for Environmental Enteropathy

Not Applicable

Completed

• Conditions: Environmental Enteropathy
• Interventions: Drug: Placebo; Drug: Albendazole; Dietary Supplement: Zinc; Dietary Supplement: Multiple Micronutrient Supplement

• Registration Number: NCT02253095
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-30
• Study Start: 2014-10
• Study First Posted: 2014-10-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Intervention Arm	Zinc	single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Multiple Intervention Arm	Multiple Micronutrient Supplement	single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Placebo	Placebo	three placebos
Multiple Intervention Arm	Albendazole	single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients

Primary Outcome Measures

Name	Time	Method
Dual Sugar Absorption Test	24 weeks	lactulose-mannitol ratio in urine

Secondary Outcome Measures

Name	Time	Method
Lactulose Excretion	24 weeks	percentage of ingested lactulose excreted in urine
Mannitol Excretion	24 weeks	percentage of ingested mannitol excreted in urine

Trial Locations

Locations (1)

Limela Rural Site; 🇲🇼 Limela, Machinga Distric, Malawi