Effect of zinc added to a daily small-quantity lipid-based nutrient supplement on diarrhoea, malaria, fever and respiratory infections in young children in rural Burkina Faso: a cluster-randomised trial
What this study found
Adding zinc to SQ-LNS did not reduce diarrhoea, malaria, fever, or respiratory infections, and no zinc dose appeared superior. Diarrhoea showed no between-group difference; overall longitudinal prevalence was 3.1% and incidence was 1.10 plus or minus 1.03 episodes per 100 child-days. Malaria duration was similar across arms (2.86, 2.99, 2.95, and 2.99 days; p=0.683), as was fever duration (2.47, 2.50, 2.49, and 2.53 days; p=0.733). Serious adverse events were not different by group overall (70 SAEs, p=0.497).
- Study & population
- Community-based, double-blind, cluster-randomised trial in 25 villages in the Dandé health district of rural southwestern Burkina Faso.
- Intervention
- Three active regimens were tested in 20 g/day small-quantity lipid-based nutrient supplement (SQ-LNS) given daily with meals from about 9 to 18 months of age: SQ-LNS with 5 mg added zinc (LNS-Zn5), SQ-LNS with 10 mg added zinc (LNS-Zn10), and SQ-LNS with 5 mg added zinc plus a 5 mg zinc sulfate tablet taken once…
- Key limitation
- The trial did not show benefit despite biologically plausible dosing, suggesting that zinc absorption or adherence may have been inadequate, or that iron in SQ-LNS may have attenuated zinc effects.
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Open PDFOriginal abstract
Objective Preventive zinc supplementation in the form of tablets or syrup reduces the incidence of diarrhoea and acute lower respiratory tract infections (RTI), but its effect on malaria is inconsistent. When zinc is administered with other micronutrients or foods, its effect is also uncertain. We assessed the effects of different amounts and sources of zinc on the frequency of diarrhoea, malaria, fever and RTI in young children. Design, setting and populations This community-based, double-blind, placebo-controlled, cluster-randomised trial of 2435 children 9 months of age was carried out between April 2010 and July 2012 in rural southwestern Burkina Faso. Interventions Participants were randomly assigned at the concession level to receive daily 1 of 4 interventions for 9 months: (1) 20 g small-quantity lipid-based nutrient supplement (SQ-LNS) without zinc and placebo tablet, (2) 20 g SQ-LNS with 5 mg zinc and placebo tablet, (3) 20 g SQ-LNS with 10 mg zinc and placebo tablet or (4) 20 g SQ-LNS without zinc and 5 mg zinc tablet. Participants were visited weekly in their homes for morbidity surveillance for 9 months, and those with uncomplicated diarrhoea and malaria received treatment from the study field workers in the community. Main outcomes Incidence and longitudinal prevalence of diarrhoea, malaria, fever, and lower and upper RTI by intervention group. Results The incidence of diarrhoea, malaria and fever was 1.10 (±1.03 SD), 0.61 (±0.66 SD) and 1.49 (±1.12 SD) episodes per 100 child-days at risk, respectively, and did not differ by intervention group (p=0.589, p=0.856 and p=0.830, respectively). The longitudinal prevalence of acute lower RTI (0.1%; 95% IC 0.1–0.2%) and of upper RTI (7.8%; 95% IC 7.1–8.4%) did not differ among groups (p=0.234 and p=0.501, respectively). Conclusions Inclusion of 5 or 10 mg zinc in SQ-LNS and provision of 5 mg zinc dispersible tablet along with SQ-LNS had no impact on the incidence of diarrhoea, malaria and fever or the longitudinal prevalence of RTI compared with SQ-LNS without zinc in this population. Trial registration number NCT00944281.