Title
ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
ω3 Long-chain Polyunsaturated Fatty Acids for Healthy Growth and Development of Infants and Young Children in the Gilgel Gibe Hydroelectric Dam Area, Ethiopia.
Phase
N/ALead Sponsor
Ghent UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Child MalnutritionIntervention/Treatment
fish oil ...Study Participants
720New 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:
To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating mothers and infant on infant growth, morbidity, nutritional status and development:
To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
Omega 3 food supplement + Omega 3 capsule.
Omega 3 food supplement + Control Capsule.
Food supplement control + Omega 3 Capsule.
Food supplement control + Control Capsule.
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