Abstract
BackgroundChildren with severe acute malnutrition (SAM) have inadequate levels of fatty acids (FAs) and limited capacity for enteral nutritional rehabilitation. We hypothesized that topical high-linoleate sunflower seed oil (SSO) would be effective adjunctive treatment for children with SAM.MethodsThis study tested a prespecified secondary endpoint of a randomized, controlled, unblinded clinical trial with 212 children with SAM aged 2 to 24 months in two strata (2 to < 6 months, 6 to 24 months in a 1:2 ratio) at Dhaka Hospital of icddr,b, Bangladesh between January 2016 and December 2017. All children received standard-of-care management of SAM. Children randomized to the emollient group also received whole-body applications of 3 g/kg SSO three times daily for 10 days. We applied difference-in-difference analysis and unsupervised clustering analysis using t-distributed stochastic neighbor embedding (t-SNE) to visualize changes in FA levels in blood from day 0 to day 10 of children with SAM treated with emollient compared to no-emollient.ResultsEmollient therapy led to systematically higher increases in 26 of 29 FAs over time compared to the control. These effects were driven primarily by changes in younger subjects (27 of 29 FAs). Several FAs, especially those most abundant in SSO showed high-magnitude but non-significant incremental increases from day 0 to day 10 in the emollient group vs. the no-emollient group; for linoleic acid, a 237 μg/mL increase was attributable to enteral feeding and an incremental 98 μg/mL increase (41%) was due to emollient therapy. Behenic acid (22:0), gamma-linolenic acid (18:3n6), and eicosapentaenoic acid (20:5n3) were significantly increased in the younger age stratum; minimal changes were seen in the older children.ConclusionsSSO therapy for SAM augmented the impact of enteral feeding in increasing levels of several FAs in young children. Further research is warranted into optimizing this novel approach for nutritional rehabilitation of children with SAM, especially those < 6 months.Trial registrationClinicalTrials.gov: NCT02616289.
Highlights
Severe acute malnutrition (SAM) affects an estimated 13.6 million children [1] – 300,000 in Bangladesh [2] – and causes about 500,000 deaths annually among underfive year-old children globally [2]
Participants were recruited at Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh, which annually treats more than 160,000 patients free-of-cost, the majority (59%) of whom are under 5 y old and from low-income families
Sample size Given the lack of literature to enable us to preset specific endpoints around which we could power this study, we did not set out to detect a predetermined value of minimal important difference in a particular fatty acid or set of fatty acids; we aimed to explore whether there was a suggestion of differences in trends between the two study arms
Summary
Severe acute malnutrition (SAM) affects an estimated 13.6 million children [1] – 300,000 in Bangladesh [2] – and causes about 500,000 deaths annually among underfive year-old children globally [2]. One-half to two-thirds of children with SAM present with diarrhea associated with enteropathy, maldigestion and malabsorption of dietary lipids, and increased intestinal permeability [3,4,5,6,7,8]. This leads to depletion of nutrients and useful gut microbiota, further resulting in deficiencies in energy harvest, vitamin biosynthesis and immune protection, and in increased risk of systemic invasion by microbial pathogens [9, 10]. We hypothesized that topical high-linoleate sunflower seed oil (SSO) would be effective adjunctive treatment for children with SAM
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