NCT01440608

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

Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Enteropathy

Interventions

Type	Name	Description
DRUG	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
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.
DIETARY_SUPPLEMENT	High-dose Zinc	Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-26
• Last updated: 2012-03-06

Locations

1 site across 1 country: Malawi