| Paul Sondo, Marc Christian Tahita, Toussaint Rouamba, Karim Derra, Bérenger Kaboré, Cheick Sa"id Compaoré, Florence Ouédraogo, Eli Rouamba, Hamidou Ilboudo, Estelle A"issa 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) (Journal Article) In: Trials, vol. 22, no. 1, pp. 360, 2021, ISSN: 1745-6215, (PMID: 34030705
PMCID: PMC8142067). @article{Sondo2021-kc,
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)},
author = {Paul Sondo and Marc Christian Tahita and Toussaint Rouamba and Karim Derra and B\'{e}renger Kabor\'{e} and Cheick Sa"id Compaor\'{e} and Florence Ou\'{e}draogo and Eli Rouamba and Hamidou Ilboudo and Estelle A"issa Bambara and Macaire Nana and Edmond Yabr\'{e} Sawadogo and Hermann Sorgho and Athanase Mwinessobaonfou Som\'{e} and Innocent Val\'{e}a and Prabin Dahal and Maminata Traor\'{e}/Coulibaly and Halidou Tinto},
doi = {10.1186/s13063-021-05320-7},
issn = {1745-6215},
year = {2021},
date = {2021-05-24},
urldate = {2021-05-24},
journal = {Trials},
volume = {22},
number = {1},
pages = {360},
publisher = {Springer Science and Business Media LLC},
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.},
note = {PMID: 34030705
PMCID: PMC8142067},
keywords = {Antimalarials/adverse effects, Burkina Faso/epidemiology, Chemoprevention, Child, Child Nutrition Disorders, Dietary Supplements, Humans, Infant, Malaria, Malaria/diagnosis/epidemiology/prevention \& control, Malnutrition, Malnutrition/diagnosis/drug therapy/prevention \& control, Pharmaceutical Preparations, Plumpy’Doz™, Preschool, Randomized controlled trial, Seasonal chemoprevention, Seasons, Vitamin A, Vitamin A/adverse effects, Zinc},
pubstate = {published},
tppubtype = {article}
}
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. |