PMID- 34030705 OWN - NLM STAT- MEDLINE DCOM- 20210617 LR - 20210617 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 May 24 TI - 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). PG - 360 LID - 10.1186/s13063-021-05320-7 [doi] LID - 360 AB - 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. FAU - Sondo, Paul AU - Sondo P AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. paulsondo@yahoo.fr. FAU - Tahita, Marc Christian AU - Tahita MC AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Rouamba, Toussaint AU - Rouamba T AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Derra, Karim AU - Derra K AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Kabore, Berenger AU - Kabore B AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Compaore, Cheick Said AU - Compaore CS AD - National Malaria Control Program, Ministry of Health, Ouagadougou, Burkina Faso. FAU - Ouedraogo, Florence AU - Ouedraogo F AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Rouamba, Eli AU - Rouamba E AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Ilboudo, Hamidou AU - Ilboudo H AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Bambara, Estelle Aissa AU - Bambara EA AD - Nutrition Direction, Ministry of Health, Ouagadougou, Burkina Faso. FAU - Nana, Macaire AU - Nana M AD - Health District of Nanoro, Ministry of Health, Nanoro, Burkina Faso. FAU - Sawadogo, Edmond Yabre AU - Sawadogo EY AD - Health District of Nanoro, Ministry of Health, Nanoro, Burkina Faso. FAU - Sorgho, Hermann AU - Sorgho H AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Some, Athanase Mwinessobaonfou AU - Some AM AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Valea, Innocent AU - Valea I AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Dahal, Prabin AU - Dahal P AD - Infectious Diseases Data Observatory (IDDO), University of Oxford, Oxford, UK. FAU - Traore/Coulibaly, Maminata AU - Traore/Coulibaly M AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. FAU - Tinto, Halidou AU - Tinto H AD - Institut de Recherche en Sciences de la Sante (IRSS)/Clinical Research Unit of Nanoro (CRUN), Nanoro, Burkina Faso. LA - eng SI - ClinicalTrials.gov/NCT04238845 GR - TMA2018CDF-2365/European & Developing Countries Clinical Trials Partnership (EDCTP)/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20210524 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Antimalarials) RN - 0 (Pharmaceutical Preparations) RN - 11103-57-4 (Vitamin A) RN - J41CSQ7QDS (Zinc) SB - IM MH - *Antimalarials/adverse effects MH - Burkina Faso/epidemiology MH - Chemoprevention MH - Child MH - *Child Nutrition Disorders MH - Child, Preschool MH - Dietary Supplements MH - Humans MH - Infant MH - *Malaria/diagnosis/epidemiology/prevention & control MH - *Malnutrition/diagnosis/drug therapy/prevention & control MH - *Pharmaceutical Preparations MH - Seasons MH - Vitamin A/adverse effects MH - Zinc PMC - PMC8142067 OTO - NOTNLM OT - Malaria OT - Malnutrition OT - Plumpy'Doz OT - Randomized controlled trial OT - Seasonal chemoprevention OT - Vitamin A OT - Zinc COIS- The authors declare that they have no competing interests. EDAT- 2021/05/26 06:00 MHDA- 2021/06/22 06:00 PMCR- 2021/05/24 CRDT- 2021/05/25 05:50 PHST- 2020/09/24 00:00 [received] PHST- 2021/05/08 00:00 [accepted] PHST- 2021/05/25 05:50 [entrez] PHST- 2021/05/26 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2021/05/24 00:00 [pmc-release] AID - 10.1186/s13063-021-05320-7 [pii] AID - 5320 [pii] AID - 10.1186/s13063-021-05320-7 [doi] PST - epublish SO - Trials. 2021 May 24;22(1):360. doi: 10.1186/s13063-021-05320-7.