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| Name | Class |
|---|---|
| Jimma University | OTHER |
| VLIR Institutional University Collaboration Programme | UNKNOWN |
| Nutrition Tiers Monde | UNKNOWN |
| Nutricia Research Fundation |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food supplement Intervention - Capsule Intervention | Experimental | Omega 3 food supplement + Omega 3 capsule. |
|
| Food Supplement Intervention - Capsule Control | Experimental | Omega 3 food supplement + Control Capsule. |
|
| Food Supplement Control - Capusle Intervention | Experimental | Food supplement control + Omega 3 Capsule. |
|
| Food Supplement Control - Capsule Control | Active Comparator | Food supplement control + Control Capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish powder corn-soy blend'+ Fish oil capsule. | Dietary Supplement | Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Kolsteren, MD, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jimma University | Jimma | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33159163 | Derived | 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. | |
| 30544211 |
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| OTHER |
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| Fish powder corn-soy blend + corn oil capsule. | Dietary Supplement | 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. | Dietary Supplement | 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. | Dietary Supplement | control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months. |
|
| 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 |
| 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. |
| 29566189 | Derived | 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. |
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003314 | Corn Oil |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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