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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
225
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
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.
Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
Saint Louis Nutrition Project
Blantyre, Malawi
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time frame: 4 weeks, 7 weeks
Change in blood endoCAb
Time frame: 7 weeks
Change in fecal calprotectin mRNA
Time frame: 4 weeks, 7 weeks
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