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Completed

NCT Number: NCT01593033

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

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.

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Key information

Conditions

Environmental Enteropathy

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis Nutrition Project

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil and Micronutrient Supplementation

Dietary Supplement

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

Dietary 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

Drug

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

Primary outcomes

  1. Changes in urine lactulose:mannitol (L:M) ratio following therapy course.

    Time frame: 3 months, 6 months

Secondary outcomes

  1. Changes in the expression of several fecal mRNAs

    Time frame: 3 months, 6 months

  2. Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested

    Time frame: 3 months, 6 months

  3. Change in height

    Time frame: 3 month, 6 month

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 7, 2012
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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