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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01593033

Collaborator

(none)

225

Enrollment

Location

Arms

Duration (Months)

37.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteropathy	Dietary Supplement: Fish oil and Micronutrient Supplementation Dietary Supplement: Micronutrient Supplement Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fish oil and Micronutrient Supplementation	Dietary Supplement: 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
Experimental: Micronutrient Supplementation	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
Placebo Comparator: Placebo	Drug: 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

Arm

Intervention/Treatment

Experimental: Fish oil and Micronutrient Supplementation

Dietary Supplement: 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

Experimental: Micronutrient Supplementation

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

Placebo Comparator: Placebo

Drug: 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

Outcome Measures

Primary Outcome Measures

Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [3 months, 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Louis Nutrition Project	Blantyre		Malawi

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Mark J Manary, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01593033

Other Study ID Numbers:

MJM - Fish Oil

First Posted:

May 7, 2012

Last Update Posted:

Jan 14, 2013

Last Verified:

Jan 1, 2013

Additional relevant MeSH terms:

Intestinal Diseases

Micronutrients

Trace Elements

Study Results

No Results Posted as of Jan 14, 2013