The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil 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
0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months 1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months
1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months
10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months
Saint Louis Nutrition Project
Blantyre, Malawi
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time frame: 3 months, 6 months
Changes in the expression of several fecal mRNAs
Time frame: 3 months, 6 months
Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
Time frame: 3 months, 6 months
Change in height
Time frame: 3 month, 6 month
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