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

The Washington University

Status

Completed

Conditions

Environmental Enteropathy

Treatments

Drug: Placebo

Dietary Supplement: Fish oil and Micronutrient Supplementation

Dietary Supplement: Micronutrient Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT01593033

MJM - Fish Oil

Details and patient eligibility

About

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.

Enrollment

225 patients

Sex

All

Ages

1 to 3 years old

Volunteers

Accepts Healthy Volunteers

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