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

May 3, 2012
January 11, 2013
May 2012
November 2012   (final data collection date for primary outcome measure)
Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01593033 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Environmental Enteropathy
  • 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
  • Experimental: Fish oil and Micronutrient Supplementation
    Intervention: Dietary Supplement: Fish oil and Micronutrient Supplementation
  • Experimental: Micronutrient Supplementation
    Intervention: Dietary Supplement: Micronutrient Supplement
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01593033
MJM - Fish Oil
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Mark J Manary, M.D. Washington University School of Medicine
Washington University School of Medicine
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP