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

Child Malnutrition Clinical Trial

— OME³Jim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817634
• Other study ID #: 2012/334
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 3, 2017
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

Intervention

Dietary Supplement:
• Fish powder corn-soy blend'+ Fish oil capsule.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
• Fish powder corn-soy blend + corn oil capsule.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
• Corn-soy blend + fish oil capsule.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
• Corn-soy blend + corn oil capsule.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

Locations

Country	Name	City	State
Ethiopia	Jimma University	Jimma

Sponsors (5)

Lead Sponsor	Collaborator
University Ghent	Jimma University, Nutricia Research Fundation, Nutrition Tiers Monde, VLIR Institutional University Collaboration Programme

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	Head circumference up to 12 months after inclusion	Head circumference measurement.	Monthly up to 12 months after inclusion
Secondary	Mid-upper arm circumference up to 12 months after inclusion.	Mid-upper arm circumference.	Monthly until 12 months after inclusion.
Secondary	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.
Secondary	Prevalence of wasting (WHZ <-2) until 12 months after inclusion.	According to WHO 2006 growth reference chart.	6-monthly until 12 months after inclusion
Secondary	C-reactive protein concentration until 12 months after inclusion	C-reactive protein concentration.	6-monthly until 12 months after inclusion
Secondary	Haemoglobin concentration until 12 months	Haemoglobin concentration in blood sample.	6-monthly until 12 months after inclusion
Secondary	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
Secondary	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
Secondary	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