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

Primary Purpose

Environmental Enteropathy

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Fish oil and Micronutrient Supplementation
Micronutrient Supplement
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Environmental Enteropathy

Eligibility Criteria

1 Year - 3 Years (Child)All SexesAccepts 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

Sites / Locations

  • Saint Louis Nutrition Project

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fish oil and Micronutrient Supplementation

Micronutrient Supplementation

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in urine lactulose:mannitol (L:M) ratio following therapy course.

Secondary Outcome Measures

Changes in the expression of several fecal mRNAs
Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
Change in height

Full Information

First Posted
May 3, 2012
Last Updated
January 11, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01593033
Brief Title
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Enteropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil and Micronutrient Supplementation
Arm Type
Experimental
Arm Title
Micronutrient Supplementation
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil and Micronutrient Supplementation
Intervention Description
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
Intervention Name(s)
Micronutrient Supplement
Intervention Description
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
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
Changes in the expression of several fecal mRNAs
Time Frame
3 months, 6 months
Title
Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
Time Frame
3 months, 6 months
Title
Change in height
Time Frame
3 month, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis Nutrition Project
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
25411039
Citation
Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1.
Results Reference
derived

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

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