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

NCT01593033 | Completed

• 1 other identifier: MJM - Fish Oil
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Environmental Enteropathy

Outcome Measures

Primary Outcomes (1)

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

  3 months, 6 months

Secondary Outcomes (3)

• Changes in the expression of several fecal mRNAs

  3 months, 6 months

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

  3 months, 6 months

• Change in height

  3 month, 6 month

Study Arms (3)

Fish oil and Micronutrient Supplementation

EXPERIMENTAL

Dietary Supplement: Fish oil and Micronutrient Supplementation

Micronutrient Supplementation

EXPERIMENTAL

Dietary Supplement: Micronutrient Supplement

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

Fish oil and Micronutrient Supplementation

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

Micronutrient Supplementation

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

Placebo

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Lives in study villages
• Will not move in next 6 months
• Caregiver willing to give intervention daily for 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Saint Louis Nutrition Project

Blantyre, Malawi

Location

Related Publications (1)

• Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1.

  PMID: 25411039 DERIVED

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Mark J Manary, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

MA (1)