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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593033
First Posted: May 7, 2012
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention
Environmental Enteropathy Dietary Supplement: Fish oil and Micronutrient Supplementation Dietary Supplement: Micronutrient Supplement Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [ Time Frame: 3 months, 6 months ]

Secondary Outcome 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 ]

Enrollment: 225
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish oil and Micronutrient Supplementation 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

Experimental: Micronutrient Supplementation 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
Placebo Comparator: Placebo 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593033


Locations
Malawi
Saint Louis Nutrition Project
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark J Manary, M.D. Washington University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01593033     History of Changes
Other Study ID Numbers: MJM - Fish Oil
First Submitted: May 3, 2012
First Posted: May 7, 2012
Last Update Posted: January 14, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs