The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial

Abstract

Objective: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children.

Design: Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %.

Setting: Namwera and Mangochi catchment areas in rural Malawi.

Subjects: Infants aged 6 months (n 1932).

Results: The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups.

Conclusions: Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.

Trial registration: ClinicalTrials.gov NCT00945698.

Keywords: Children; Infectious disease morbidity; Iron; Lipid-based nutrient supplements; Low-income countries.

Fig. 1

Participant flow in the present study (LNS, lipid-based nutrient supplement)

Fig. 2

Plot of selected morbidity outcomes among rural Malawian infants and young children, iLiNS-DOSE study, November 2009–May 2012. All intervention groups receiving lipid-based nutrient supplement (LNS) were pooled together and compared with the control group, with results (●) reported as incidence rate ratios (IRR), relative risks (RR) or geometric means ratios (GMR) with their 95 % CI (represented by horizontal lines). The vertical dashed line represents the margin of non-inferiority. The solid line represents the null effect. None of the point estimates and their 95 % CI fell entirely above the non-inferiority margin (1·20; ▲). We conclude that LNS is does not increase morbidity