Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-06 @ 10:49 AM
Study NCT ID:
NCT01817634
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
Sponsor:
University Ghent
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OME³Jim
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: