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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01593033

Enrollment

225

Registered

2012-05-07

Start date

2012-05-31

Completion date

2012-11-30

Last updated

2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Enteropathy

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.

Interventions

DIETARY_SUPPLEMENTFish 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_SUPPLEMENTMicronutrient 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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.	3 months, 6 months

Secondary

Measure	Time frame
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

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026