Clinical trial NCT01817634: ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
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
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Keywords: Malnutrition.
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Jimma University
name: VLIR Institutional University Collaboration Programme
name: Nutrition Tiers Monde
name: Nutricia Research Fundation
First posted: 2013-03-25
Enrollment: 720
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in length-for-age Z-score over time up to 12 months.
timeFrame: Every month since baseline until 12 months.
measure: Development score after study inclusion until 12 months after inclusion.
timeFrame: 6-monthly since baseline up to 12 months.
Secondary outcomes:
measure: Weight-for-length Z-score up to 12 months.
timeFrame: 6-monthly up to 12 months.
measure: Head circumference up to 12 months after inclusion
timeFrame: Monthly up to 12 months after inclusion
measure: Mid-upper arm circumference up to 12 months after inclusion.
timeFrame: Monthly until 12 months after inclusion.
measure: Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.
timeFrame: 6-monthly until 12 months after inclusion.
measure: Prevalence of wasting (WHZ <-2) until 12 months after inclusion.
timeFrame: 6-monthly until 12 months after inclusion
measure: C-reactive protein concentration until 12 months after inclusion
timeFrame: 6-monthly until 12 months after inclusion
measure: Haemoglobin concentration until 12 months
timeFrame: 6-monthly until 12 months after inclusion
measure: Infant morbidity at weekly intervals.
timeFrame: weekly until 12 months after inclusion
measure: Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion
timeFrame: 6-monthly until 12 months after inclusion
measure: Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.
timeFrame: 6-monthly until 12 months after inclusion
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
Study officials:
affiliation: University Ghent
name: Patrick Kolsteren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.