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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:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01593033
First received: May 3, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Fish oil
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the expression of several fecal mRNAs [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: 3 month, 6 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 in St. Louis
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01593033     History of Changes
Other Study ID Numbers: MJM - Fish Oil
Study First Received: May 3, 2012
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board
Malawi: College of Medicine Research and Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013