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Title: Lipid-based nutrient supplements do not affect the risk of malaria or respiratory morbidity in 6- to 18-month-old Malawian children in a randomized controlled trial

Author
item MANGANI, CHARLES - UNIVERSITY OF MALAWI
item ASHORN, PER - UNIVERSITY OF TAMPERE MEDICAL SCHOOL
item MALETA, KENNETH - UNIVERSITY OF MALAWI
item PHUKA, JOHN - UNIVERSITY OF MALAWI
item THAKWALAKWA, CHRISSIE - UNIVERSITY OF MALAWI
item DEWEY, KATHRYN - UNIVERSITY OF CALIFORNIA
item MANARY, MARK - CHILDREN'S NUTRITION RESEARCH CENTER (CNRC)
item PUUMALAINEN, TANELI - MINISTRY OF SOCIAL AFFAIRS AND HEALTH
item CHEUNG, YIN BUN - NATIONAL UNIVERSITY OF SINGAPORE

Submitted to: Journal of Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/26/2014
Publication Date: 11/1/2014
Citation: Mangani, C., Ashorn, P., Maleta, K., Phuka, J., Thakwalakwa, C., Dewey, K., Manary, M.J., Puumalainen, T., Cheung, Y. 2014. Lipid-based nutrient supplements do not affect the risk of malaria or respiratory morbidity in 6- to 18-month-old Malawian children in a randomized controlled trial. Journal of Nutrition. 144(11):1835-1842.

Interpretive Summary: There is concern for increased infections when using iron-fortified nutrient supplement to promote child growth and development in areas where malaria is continuously present. A large number of Malawian children were given one of 4 types of food supplements and infections were monitored. These food supplements did not result in increases in malaria or respiratory illnesses. Additional studies are necessary to evaluate the nutritional impact in these international settings.

Technical Abstract: There is evidence to support the use of lipid-based nutrient supplements (LNSs) to promote child growth and development in low-income countries, but there is also a concern regarding the safety of using iron-fortified products in malaria-endemic areas. The objective of this study was to test the hypothesis that 6- to 18-mo-old rural Malawian children receiving iron-containing (6 mg/d) LNSs would not have excess morbidity compared with infants receiving no supplementation. A randomized controlled trial allocated 840 children to receive daily supplementation with 54 g/d LNS with milk protein base (milk-LNS), 54 g/d LNS with soy protein base (soy-LNS), 71 g/d corn-soy blend (CSB), or no supplementation from 6 to 18 mo of age. Morbidity was compared using a non-inferiority margin set at 20% excess morbidity in supplemented groups compared with the nonsupplemented group. Baseline characteristics were similar across groups. The proportion of days with febrile illness between 6 and 18 mo was 4.9%, and there were no differences between the groups: 4.9% (95% CI: 4.3, 5.5%), 4.5% (95% CI: 3.9, 5.1%), 4.7% (95% CI: 4.1, 5.3%), and 5.5% (95% CI: 4.7-6.3%) in the milk-LNS, soy-LNS, CSB, and control groups, respectively. The proportion of days with respiratory problems and diarrhea between 6 and 18 mo also did not differ between groups. Compared with controls, the incident rate ratio (95% CI) for clinical malaria was 0.80 (0.59, 1.09), 0.77 (0.56, 1.06), and 0.79 (0.58, 1.08) in milk-LNS, soy-LNS, and CSB, respectively, with 95% CIs confirming non-inferiority. The incidence of febrile episodes, diarrhea, respiratory problems or admission to hospital, prevalence of malaria parasitemia throughout the follow-up, and mean change in hemoglobin concentration from baseline were also similar between the groups. Daily supplementation with 54 g of milk-based or soy protein-based LNS or 71 g of CSB did not result in increases in malaria or respiratory morbidity in children in a malaria-endemic setting. However, we could not conclude whether LNSs did or did not increase diarrheal morbidity.