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

Environmental Enteropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593033
• Other study ID #: MJM - Fish Oil
• Status: Completed
• Phase: N/A
• First received: May 3, 2012
• Last updated: January 11, 2013
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMalawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Environmental Enteropathy
• Intestinal Diseases

Intervention

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
• 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

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

Locations

Country	Name	City	State
Malawi	Saint Louis Nutrition Project	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urine lactulose:mannitol (L:M) ratio following therapy course.		3 months, 6 months	No
Secondary	Changes in the expression of several fecal mRNAs		3 months, 6 months	No
Secondary	Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested		3 months, 6 months	No
Secondary	Change in height		3 month, 6 month	No