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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.
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 %.
Namwera and Mangochi catchment areas in rural Malawi.
Infants aged 6 months (n 1932).
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.
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.
To determine if supplementation with corn–soya blend (CSB) or lipid-based nutrient supplement (LNS) improved the weight gain of moderately underweight infants and children when provided through the national health service.
A randomised, controlled, assessor-blinded clinical trial. Infants and children were randomised to receive for 12 weeks an average daily ration of 71 g CSB or 43 g LNS, providing 1188 kJ and 920 kJ, respectively, or no supplement (control). Main outcome was weight gain. Secondary outcomes included changes in anthropometric indices and incidence of serious adverse events. Intention-to-treat analyses were used.
Kukalanga, Koche, Katema and Jalasi health centres in Mangochi District, rural Malawi.
Underweight (weight-for-age Z-score <−2) infants and children aged 6–15 months (n 299).
Mean weight gain was 630 g, 680 g and 750 g in control, CSB and LNS groups, respectively (P = 0·21). When adjusted for baseline age, children receiving LNS gained on average 90 g more weight (P = 0·185) and their weight-for-length Z-score increased 0·22 more (P = 0·049) compared with those receiving no supplementation. No statistically significant differences were observed between the CSB and control groups in mean weight and length gain.
LNS supplementation provided during the lean season via through the national health service was associated with a modest increase in weight. However, the effect size was lower than that previously reported under more controlled research settings.
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