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

Not Applicable

Completed

• Conditions: Environmental Enteropathy
• Interventions: Dietary Supplement: Fish oil and Micronutrient Supplementation; Dietary Supplement: Micronutrient Supplement; Drug: Placebo

• Registration Number: NCT01593033
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil and Micronutrient Supplementation	Fish oil and Micronutrient Supplementation	-
Micronutrient Supplementation	Micronutrient Supplement	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.	3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Louis Nutrition Project; 🇲🇼 Blantyre, Malawi