NCT01593033

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Environmental Enteropathy

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-05-07
• Last updated: 2013-01-14

Locations

1 site across 1 country: Malawi