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)
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...
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| Format: | Article |
| Language: | English |
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BMC
2021-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05320-7 |
| _version_ | 1819047612889694208 |
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| author | Paul Sondo Marc Christian Tahita Toussaint Rouamba Karim Derra Bérenger Kaboré Cheick Saïd Compaoré Florence Ouédraogo Eli Rouamba Hamidou Ilboudo Estelle Aïssa Bambara Macaire Nana Edmond Yabré Sawadogo Hermann Sorgho Athanase Mwinessobaonfou Somé Innocent Valéa Prabin Dahal Maminata Traoré/Coulibaly Halidou Tinto |
| author_facet | Paul Sondo Marc Christian Tahita Toussaint Rouamba Karim Derra Bérenger Kaboré Cheick Saïd Compaoré Florence Ouédraogo Eli Rouamba Hamidou Ilboudo Estelle Aïssa Bambara Macaire Nana Edmond Yabré Sawadogo Hermann Sorgho Athanase Mwinessobaonfou Somé Innocent Valéa Prabin Dahal Maminata Traoré/Coulibaly Halidou Tinto |
| author_sort | Paul Sondo |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-21T11:03:08Z |
| format | Article |
| id | doaj.art-2ad7b0c61bb042b5a72fb8cf54f4634a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T11:03:08Z |
| publishDate | 2021-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2ad7b0c61bb042b5a72fb8cf54f4634a2022-12-21T19:06:18ZengBMCTrials1745-62152021-05-0122111010.1186/s13063-021-05320-7Assessment 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)Paul Sondo0Marc Christian Tahita1Toussaint Rouamba2Karim Derra3Bérenger Kaboré4Cheick Saïd Compaoré5Florence Ouédraogo6Eli Rouamba7Hamidou Ilboudo8Estelle Aïssa Bambara9Macaire Nana10Edmond Yabré Sawadogo11Hermann Sorgho12Athanase Mwinessobaonfou Somé13Innocent Valéa14Prabin Dahal15Maminata Traoré/Coulibaly16Halidou Tinto17Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)National Malaria Control Program, Ministry of HealthInstitut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Nutrition Direction, Ministry of HealthHealth District of Nanoro, Ministry of HealthHealth District of Nanoro, Ministry of HealthInstitut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Infectious Diseases Data Observatory (IDDO), University of OxfordInstitut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN)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/NCT04238845https://doi.org/10.1186/s13063-021-05320-7MalariaMalnutritionSeasonal chemopreventionPlumpy’Doz™Vitamin AZinc |
| spellingShingle | Paul Sondo Marc Christian Tahita Toussaint Rouamba Karim Derra Bérenger Kaboré Cheick Saïd Compaoré Florence Ouédraogo Eli Rouamba Hamidou Ilboudo Estelle Aïssa Bambara Macaire Nana Edmond Yabré Sawadogo Hermann Sorgho Athanase Mwinessobaonfou Somé Innocent Valéa Prabin Dahal Maminata Traoré/Coulibaly Halidou Tinto 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) Trials Malaria Malnutrition Seasonal chemoprevention Plumpy’Doz™ Vitamin A Zinc |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Malaria Malnutrition Seasonal chemoprevention Plumpy’Doz™ Vitamin A Zinc |
| url | https://doi.org/10.1186/s13063-021-05320-7 |
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