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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
  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 August 19, 2014