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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Environmental Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fish oil and Micronutrient Supplementation

Group Type EXPERIMENTAL

Fish oil and Micronutrient Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Micronutrient Supplementation

Group Type EXPERIMENTAL

Micronutrient Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Fish oil and Micronutrient Supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Micronutrient Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DRUG

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes