Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children

Conditions
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Environmental Enteropathy

Intervention / Treatment
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* Dietary Supplement: Fish oil and Micronutrient Supplementation
* Dietary Supplement: Micronutrient Supplement
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-3 years of age Lives in study villages Will not move in next 6 months Caregiver willing to give intervention daily for 6 months Exclusion Criteria: Unable to drink 20 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 Caregiver refusal to participate and return for 3 and 6 month follow-ups

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil and Micronutrient Supplementation<br> | Dietary Supplement: Fish oil and Micronutrient Supplementation<br>* 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<br>|
| Experimental: Micronutrient Supplementation<br> | Dietary Supplement: Micronutrient Supplement<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urine lactulose:mannitol (L:M) ratio following therapy course. |  | 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the expression of several fecal mRNAs |  | 3 months, 6 months | 
| Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested |  | 3 months, 6 months | 
| Change in height |  | 3 month, 6 month |