Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: November 2012
Interventions
- 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
Arms, Groups and Cohorts
- Experimental: Fish oil and Micronutrient Supplementation
- Experimental: Micronutrient Supplementation
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
- Time Frame: 3 months, 6 months
Secondary Measures
- Changes in the expression of several fecal mRNAs
- Time Frame: 3 months, 6 months
- Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
- Time Frame: 3 months, 6 months
- Change in height
- Time Frame: 3 month, 6 month
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 1 Year
Maximum Age: 3 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Washington University School of Medicine
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Mark J Manary, M.D., Principal Investigator, Washington University School of Medicine
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