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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
720
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.
Jimma University
Jimma, Ethiopia
Change in length-for-age Z-score over time up to 12 months.
Length-for-age Z-score using the WHO 2006 growth reference chart.
Time frame: Every month since baseline until 12 months.
Development score after study inclusion until 12 months after inclusion.
Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.
Time frame: 6-monthly since baseline up to 12 months.
Weight-for-length Z-score up to 12 months.
Weight-for-length Z-score: WHO 2006 growth reference chart.
Time frame: 6-monthly up to 12 months.
Head circumference up to 12 months after inclusion
Head circumference measurement.
Time frame: Monthly up to 12 months after inclusion
Mid-upper arm circumference up to 12 months after inclusion.
Mid-upper arm circumference.
Time frame: Monthly until 12 months after inclusion.
Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.
According to WHO 2006 growth reference chart.
Time frame: 6-monthly until 12 months after inclusion.
Prevalence of wasting (WHZ <-2) until 12 months after inclusion.
According to WHO 2006 growth reference chart.
Time frame: 6-monthly until 12 months after inclusion
C-reactive protein concentration until 12 months after inclusion
C-reactive protein concentration.
Time frame: 6-monthly until 12 months after inclusion
Haemoglobin concentration until 12 months
Haemoglobin concentration in blood sample.
Time frame: 6-monthly until 12 months after inclusion
Infant morbidity at weekly intervals.
Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.
Time frame: weekly until 12 months after inclusion
Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion
Breast milk collections to determine milk levels of DHA/EPA/AA.
Time frame: 6-monthly until 12 months after inclusion
Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.
Blood sample for measuring infant blood levers of DHA/EPA/AA.
Time frame: 6-monthly until 12 months after inclusion
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