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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01593033
Other study ID # MJM - Fish Oil
Secondary ID
Status Completed
Phase N/A
First received May 3, 2012
Last updated January 11, 2013
Start date May 2012
Est. completion date November 2012

Study information

Verified date January 2013
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardMalawi: College of Medicine Research and Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 3 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Malawi Saint Louis Nutrition Project Blantyre

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in urine lactulose:mannitol (L:M) ratio following therapy course. 3 months, 6 months No
Secondary Changes in the expression of several fecal mRNAs 3 months, 6 months No
Secondary Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested 3 months, 6 months No
Secondary Change in height 3 month, 6 month No
See also
  Status Clinical Trial Phase
Completed NCT02253095 - Combined Package of Interventions for Environmental Enteropathy N/A
Completed NCT01832636 - Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy Phase 3
Active, not recruiting NCT04565821 - Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe N/A
Active, not recruiting NCT03713502 - Enteropathy and Diabetes in HIV Patients
Not yet recruiting NCT05608928 - Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia Phase 2
Completed NCT02472301 - The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds N/A