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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