Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with Vitamin A, Zinc and Plumpy’DozTM to prevent malaria and malnutrition in children under five years old in Burkina Faso: a randomized open label trial (SMC-NUT)

Abstract • Background : Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria incidence among children aged 3-59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. Malnutrition, in particular micronutrient deficiency, appears to be one of the potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the incidence of malaria in highly prevalent malaria zone such as rural settings. Therefore, we hypothesized that a combined strategy of SMC together with a daily oral nutrients supplement will enhance the immune response and decrease the incidence of malaria and malnutrition among children under SMC coverage.• Methods : Children (6-59 months) under SMC coverage receiving Vitamin A supplementation will be randomly assigned to one of the three study arms (a) SMC+ Vitamin A alone, (b) SMC + Vitamin A + Zinc, or (c) SMC+ Vitamin A + Plumpy’Doz TM using 1:1:1 allocation ratio. After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed-up for one year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, hemoglobin measurement and spotted onto filter paper for further PCR analyses. The primary outcome measure is the incidence of malaria in each arm. Secondary outcome measures will include mid-upper arm circumference and weight gain from baseline measurements, coverage and compliance to SMC, occurrence of adverse events (AEs), and prevalence of molecular markers of antimalarial resistance comprising Pfcrt , Pfmdr1 , Pfdhfr and Pfdhps .• Discussion : This study will demonstrate an integrated strategy of malaria and malnutrition programs in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels• Trial registration NCT04238845 23/01/2020 Clinicaltrials.govhttps://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4