ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia (OME³Jim)

University Ghent

Status: Completed

Conditions: Child Malnutrition

Treatments: Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.; Dietary Supplement: Corn-soy blend + corn oil capsule.; Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.; Dietary Supplement: Corn-soy blend + fish oil capsule.

Study type: Interventional

Funder types: Other

Identifiers

NCT01817634

2012/334

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton infants
• 6-12 months old
• Not suffering from acute malnutrition (wasting): WHZ > -2 , no edema
• Infants currently being breastfed
• Anticipated local residence for the study duration
• Not planning to leave the study area for more than 1 month

Exclusion criteria

• Current supplement use or medical treatment of infant and/or mother
• Infants developing severe anemia (<70 g/L) or edema are referred to the nearby health institution for evaluation and treatment, and are omitted from the trial
• Presence of congenital abnormalities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 4 patient groups

Food supplement Intervention - Capsule Intervention

Experimental group

Description:

Omega 3 food supplement + Omega 3 capsule.

Treatment:

Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.

Food Supplement Intervention - Capsule Control

Experimental group

Description:

Omega 3 food supplement + Control Capsule.

Treatment:

Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.

Food Supplement Control - Capusle Intervention

Experimental group

Description:

Food supplement control + Omega 3 Capsule.

Treatment:

Dietary Supplement: Corn-soy blend + fish oil capsule.

Food Supplement Control - Capsule Control

Active Comparator group

Description:

Food supplement control + Control Capsule.

Treatment:

Dietary Supplement: Corn-soy blend + corn oil capsule.