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

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Enteropathy

Intervention: Albendazole (Drug); Placebo (Drug); High-dose Zinc (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Mark J Manary, MD, Principal Investigator, Affiliation: Washington University in St. Louis, School of Medicine

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes in urine lactulose:mannitol (L:M) ratio following therapy course.

Secondary outcome:

Change in blood endoCAb

Change in fecal calprotectin mRNA

Eligibility

Minimum age: 1 Year. Maximum age: 3 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Saint Louis Nutrition Project, Blantyre, Malawi
Additional Information

Starting date: October 2011
Last updated: March 2, 2012

Page last updated: August 23, 2015

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