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 endoCAbChange 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
|