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

Study Overview
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Brief Summary
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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: 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.

Official Title
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ω3 Long-chain Polyunsaturated Fatty Acids for Healthy Growth and Development of Infants and Young Children in the Gilgel Gibe Hydroelectric Dam Area, Ethiopia.

Conditions
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Child Malnutrition

Intervention / Treatment
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* Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.
* Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.
* Dietary Supplement: Corn-soy blend + fish oil capsule.
* Dietary Supplement: Corn-soy blend + corn oil capsule.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food supplement Intervention - Capsule Intervention<br>Omega 3 food supplement + Omega 3 capsule. | Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.<br>* Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.<br>|
| Experimental: Food Supplement Intervention - Capsule Control<br>Omega 3 food supplement + Control Capsule. | Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.<br>* Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.<br>|
| Experimental: Food Supplement Control - Capusle Intervention<br>Food supplement control + Omega 3 Capsule. | Dietary Supplement: Corn-soy blend + fish oil capsule.<br>* control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.<br>|
| Active Comparator: Food Supplement Control - Capsule Control<br>Food supplement control + Control Capsule. | Dietary Supplement: Corn-soy blend + corn oil capsule.<br>* control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6-monthly since baseline up to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-for-length Z-score up to 12 months. | Weight-for-length Z-score: WHO 2006 growth reference chart. | 6-monthly up to 12 months. | 
| Head circumference up to 12 months after inclusion | Head circumference measurement. | Monthly up to 12 months after inclusion | 
| Mid-upper arm circumference up to 12 months after inclusion. | Mid-upper arm circumference. | Monthly until 12 months after inclusion. | 
| Prevalence of stunting (HAZ <-2- up to 12 months after inclusion. | According to WHO 2006 growth reference chart. | 6-monthly until 12 months after inclusion. | 
| Prevalence of wasting (WHZ <-2) until 12 months after inclusion. | According to WHO 2006 growth reference chart. | 6-monthly until 12 months after inclusion | 
| C-reactive protein concentration until 12 months after inclusion | C-reactive protein concentration. | 6-monthly until 12 months after inclusion | 
| Haemoglobin concentration until 12 months | Haemoglobin concentration in blood sample. | 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. | 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. | 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. | 6-monthly until 12 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition.