ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia

Summary

New approaches are needed to prevent growth failure in children from low- and middle-income countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and energy content of complementary foods and have yielded only small to moderate effects on growth and development. There appears to be a missing link that mediates and reduces the expected beneficial effect. Child populations in LMIC show an asymptomatic environmental enteropathy that is characterized by a reduced size of the small intestinal villi, decreased gut integrity and a chronic inflammatory response in the gut. Results from studies in industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs) improve immune response and gut integrity. These reported beneficial effects could result in even more important physiological implications for children from LMIC and will ultimately contribute to their healthy growth and development.

The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through complementary foods and human milk has an effect on infant growth and development in a context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify whether intake by either or both mother and infant is more effective.

The specific objectives of the OME³Jim study are:

1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating mothers and infant on infant growth, morbidity, nutritional status and development:
4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.

Conditions

• Child Malnutrition

Interventions

DIETARY_SUPPLEMENT

Fish powder corn-soy blend'+ Fish oil capsule.

Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.

DIETARY_SUPPLEMENT

Fish powder corn-soy blend + corn oil capsule.

Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

DIETARY_SUPPLEMENT

Corn-soy blend + fish oil capsule.

control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.

DIETARY_SUPPLEMENT

Corn-soy blend + corn oil capsule.

control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

Sponsors & Collaborators

• Jimma University

  collaborator OTHER

• VLIR Institutional University Collaboration Programme

  collaborator UNKNOWN

• Nutrition Tiers Monde

  collaborator UNKNOWN

• Nutricia Research Fundation

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Patrick Kolsteren, MD, PhD · University Ghent

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• Ethiopia

Study Locations