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.