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

Not Applicable

Completed

• Conditions: Child Malnutrition
• Interventions: 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.; Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.

• Registration Number: NCT01817634
• Lead Sponsor: University Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-25
• Study Start: 2013-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food Supplement Intervention - Capsule Control	Fish powder corn-soy blend + corn oil capsule.	Omega 3 food supplement + Control Capsule.
Food Supplement Control - Capusle Intervention	Corn-soy blend + fish oil capsule.	Food supplement control + Omega 3 Capsule.
Food Supplement Control - Capsule Control	Corn-soy blend + corn oil capsule.	Food supplement control + Control Capsule.
Food supplement Intervention - Capsule Intervention	Fish powder corn-soy blend'+ Fish oil capsule.	Omega 3 food supplement + Omega 3 capsule.

Primary Outcome Measures

Name	Time	Method
Change in length-for-age Z-score over time up to 12 months.	Every month since baseline until 12 months.	Length-for-age Z-score using the WHO 2006 growth reference chart.
Development score after study inclusion until 12 months after inclusion.	6-monthly since baseline up to 12 months.	Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Weight-for-length Z-score up to 12 months.	6-monthly up to 12 months.	Weight-for-length Z-score: WHO 2006 growth reference chart.
Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.	6-monthly until 12 months after inclusion.	According to WHO 2006 growth reference chart.
C-reactive protein concentration until 12 months after inclusion	6-monthly until 12 months after inclusion	C-reactive protein concentration.
Mid-upper arm circumference up to 12 months after inclusion.	Monthly until 12 months after inclusion.	Mid-upper arm circumference.
Prevalence of wasting (WHZ <-2) until 12 months after inclusion.	6-monthly until 12 months after inclusion	According to WHO 2006 growth reference chart.
Infant morbidity at weekly intervals.	weekly until 12 months after inclusion	Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.
Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.	6-monthly until 12 months after inclusion	Blood sample for measuring infant blood levers of DHA/EPA/AA.
Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion	6-monthly until 12 months after inclusion	Breast milk collections to determine milk levels of DHA/EPA/AA.
Head circumference up to 12 months after inclusion	Monthly up to 12 months after inclusion	Head circumference measurement.
Haemoglobin concentration until 12 months	6-monthly until 12 months after inclusion	Haemoglobin concentration in blood sample.

Trial Locations

Locations (1)

Jimma University; 🇪🇹 Jimma, Ethiopia