ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia (OME³Jim)
Primary Purpose
Child Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Fish powder corn-soy blend'+ Fish oil capsule.
Fish powder corn-soy blend + corn oil capsule.
Corn-soy blend + fish oil capsule.
Corn-soy blend + corn oil capsule.
Sponsored by
About this trial
This is an interventional prevention trial for Child Malnutrition focused on measuring Malnutrition.
Eligibility Criteria
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
Sites / Locations
- Jimma University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Food supplement Intervention - Capsule Intervention
Food Supplement Intervention - Capsule Control
Food Supplement Control - Capusle Intervention
Food Supplement Control - Capsule Control
Arm Description
Omega 3 food supplement + Omega 3 capsule.
Omega 3 food supplement + Control Capsule.
Food supplement control + Omega 3 Capsule.
Food supplement control + Control Capsule.
Outcomes
Primary Outcome Measures
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.
Development score after study inclusion until 12 months after inclusion.
Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.
Secondary Outcome Measures
Weight-for-length Z-score up to 12 months.
Weight-for-length Z-score: WHO 2006 growth reference chart.
Head circumference up to 12 months after inclusion
Head circumference measurement.
Mid-upper arm circumference up to 12 months after inclusion.
Mid-upper arm circumference.
Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.
According to WHO 2006 growth reference chart.
Prevalence of wasting (WHZ <-2) until 12 months after inclusion.
According to WHO 2006 growth reference chart.
C-reactive protein concentration until 12 months after inclusion
C-reactive protein concentration.
Haemoglobin concentration until 12 months
Haemoglobin concentration in blood sample.
Infant morbidity at weekly intervals.
Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.
Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion
Breast milk collections to determine milk levels of DHA/EPA/AA.
Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.
Blood sample for measuring infant blood levers of DHA/EPA/AA.
Full Information
NCT ID
NCT01817634
First Posted
March 20, 2013
Last Updated
May 3, 2017
Sponsor
University Ghent
Collaborators
Jimma University, VLIR Institutional University Collaboration Programme, Nutrition Tiers Monde, Nutricia Research Fundation
1. Study Identification
Unique Protocol Identification Number
NCT01817634
Brief Title
ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Jimma University, VLIR Institutional University Collaboration Programme, Nutrition Tiers Monde, Nutricia Research Fundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition
Keywords
Malnutrition.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food supplement Intervention - Capsule Intervention
Arm Type
Experimental
Arm Description
Omega 3 food supplement + Omega 3 capsule.
Arm Title
Food Supplement Intervention - Capsule Control
Arm Type
Experimental
Arm Description
Omega 3 food supplement + Control Capsule.
Arm Title
Food Supplement Control - Capusle Intervention
Arm Type
Experimental
Arm Description
Food supplement control + Omega 3 Capsule.
Arm Title
Food Supplement Control - Capsule Control
Arm Type
Active Comparator
Arm Description
Food supplement control + Control Capsule.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish powder corn-soy blend'+ Fish oil capsule.
Intervention Description
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish powder corn-soy blend + corn oil capsule.
Intervention Description
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn-soy blend + fish oil capsule.
Intervention Description
control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn-soy blend + corn oil capsule.
Intervention Description
control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
Primary Outcome Measure Information:
Title
Change in length-for-age Z-score over time up to 12 months.
Description
Length-for-age Z-score using the WHO 2006 growth reference chart.
Time Frame
Every month since baseline until 12 months.
Title
Development score after study inclusion until 12 months after inclusion.
Description
Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.
Time Frame
6-monthly since baseline up to 12 months.
Secondary Outcome Measure Information:
Title
Weight-for-length Z-score up to 12 months.
Description
Weight-for-length Z-score: WHO 2006 growth reference chart.
Time Frame
6-monthly up to 12 months.
Title
Head circumference up to 12 months after inclusion
Description
Head circumference measurement.
Time Frame
Monthly up to 12 months after inclusion
Title
Mid-upper arm circumference up to 12 months after inclusion.
Description
Mid-upper arm circumference.
Time Frame
Monthly until 12 months after inclusion.
Title
Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.
Description
According to WHO 2006 growth reference chart.
Time Frame
6-monthly until 12 months after inclusion.
Title
Prevalence of wasting (WHZ <-2) until 12 months after inclusion.
Description
According to WHO 2006 growth reference chart.
Time Frame
6-monthly until 12 months after inclusion
Title
C-reactive protein concentration until 12 months after inclusion
Description
C-reactive protein concentration.
Time Frame
6-monthly until 12 months after inclusion
Title
Haemoglobin concentration until 12 months
Description
Haemoglobin concentration in blood sample.
Time Frame
6-monthly until 12 months after inclusion
Title
Infant morbidity at weekly intervals.
Description
Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.
Time Frame
weekly until 12 months after inclusion
Title
Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion
Description
Breast milk collections to determine milk levels of DHA/EPA/AA.
Time Frame
6-monthly until 12 months after inclusion
Title
Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.
Description
Blood sample for measuring infant blood levers of DHA/EPA/AA.
Time Frame
6-monthly until 12 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Kolsteren, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jimma University
City
Jimma
Country
Ethiopia
12. IPD Sharing Statement
Citations:
PubMed Identifier
33159163
Citation
Argaw A, Bouckaert KP, Wondafrash M, Kolsteren P, Lachat C, De Meulenaer B, Hanley-Cook G, Huybregts L. Effect of fish-oil supplementation on breastmilk long-chain polyunsaturated fatty acid concentration: a randomized controlled trial in rural Ethiopia. Eur J Clin Nutr. 2021 May;75(5):809-816. doi: 10.1038/s41430-020-00798-x. Epub 2020 Nov 6.
Results Reference
derived
PubMed Identifier
30544211
Citation
Argaw A, Huybregts L, Wondafrash M, Kolsteren P, Belachew T, Worku BN, Abessa TG, Bouckaert KP. Neither n-3 Long-Chain PUFA Supplementation of Mothers through Lactation nor of Offspring in a Complementary Food Affects Child Overall or Social-Emotional Development: A 2 x 2 Factorial Randomized Controlled Trial in Rural Ethiopia. J Nutr. 2019 Mar 1;149(3):505-512. doi: 10.1093/jn/nxy202.
Results Reference
derived
PubMed Identifier
29566189
Citation
Argaw A, Wondafrash M, Bouckaert KP, Kolsteren P, Lachat C, Belachew T, De Meulenaer B, Huybregts L. Effects of n-3 long-chain PUFA supplementation to lactating mothers and their breastfed children on child growth and morbidity: a 2 x 2 factorial randomized controlled trial in rural Ethiopia. Am J Clin Nutr. 2018 Mar 1;107(3):454-464. doi: 10.1093/ajcn/nqx057.
Results Reference
derived
Learn more about this trial
ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
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