1. Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)
- Author
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Prabin Dahal, Karim Derra, Eli Rouamba, Maminata Traore, Hamidou Ilboudo, Cheick Saïd Compaoré, Athanase M Some, Macaire Nana, Paul Sondo, Florence Ouedraogo, Berenger Kaboré, Innocent Valea, Halidou Tinto, Coulibaly, Hermann Sorgho, Estelle Aïssa Bambara, Marc Christian Tahita, Toussaint Rouamba, and Edmond Yabré Sawadogo
- Subjects
Medicine (General) ,Micronutrient deficiency ,030231 tropical medicine ,Medicine (miscellaneous) ,Malnutrition in children ,Chemoprevention ,Child Nutrition Disorders ,law.invention ,Plumpy’Doz™ ,Antimalarials ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,R5-920 ,Randomized controlled trial ,law ,Environmental health ,Burkina Faso ,parasitic diseases ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Child ,Vitamin A ,Seasonal chemoprevention ,business.industry ,Incidence (epidemiology) ,Malnutrition ,Infant ,medicine.disease ,Micronutrient ,Malaria ,Zinc ,Pharmaceutical Preparations ,Child, Preschool ,Dietary Supplements ,Chemoprophylaxis ,Seasons ,business - 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™ 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 1 year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, haemoglobin 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 programmes 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 ClinicalTrials.gov NCT04238845. Registered on 23 January 2020 https://clinicaltrials.gov/ct2/show/NCT04238845
- Published
- 2021