Enhanced effect of seasonal malaria chemoprevention when coupled with nutrients supplementation for preventing malaria in children under 5 years old in Burkina Faso: a randomized open label trial

Abstract

Background: In rural African settings, most of the children under the coverage of Seasonal Malaria Chemoprevention (SMC) are also undernourished at the time of SMC delivery, justifying the need for packaging malarial and nutritional interventions. This study aimed at assessing the impact of SMC by coupling the intervention with nutrients supplementation for preventing malaria in children less than 5 years old in Burkina Faso.

Methods: A randomized trial was carried out between July 2020 and June 2021 in the health district of Nanoro, Burkina Faso. Children (n = 1059) under SMC coverage were randomly assigned to one of the three study arms SMC + Vitamin A (SMC-A, n = 353) or SMC + Vitamin A + Zinc (SMC-AZc, n = 353) or SMC + Vitamin A + PlumpyDoz(tm) (SMC-APd, n = 353)-a medium quantity-lipid-based nutrient supplement (MQ-LNS). Children were followed up for one year that included an active follow-up period of 6 months with scheduled monthly home visits followed by 6 months passive follow-up. At each visit, capillary blood sample was collected for malaria diagnosis by rapid diagnosis test (RDT).

Results: Adding nutritional supplements to SMC had an effect on the incidence of malaria. A reduction of 23% (adjusted IRR = 0.77 (95%CI 0.61-0.97) in the odds of having uncomplicated malaria in SMC-APd arm but not with SMC-AZc arm adjusted IRR = 0.82 (95%CI 0.65-1.04) compare to control arm was observed. A reduction of 52%, adjusted IRR = 0.48 (95%CI 0.23-0.98) in the odds of having severe malaria was observed in SMC-APd arm compared to control arm. Besides the effect on malaria, this combined strategy had an effect on all-cause morbidity. More specifically, a reduction of morbidity odds of 24%, adjusted IRR = 0.76 (95%CI 0.60-0.94) in SMC-APd arm compared to control arm was observed. Unlike clinical episodes, no effect of nutrient supplementation on cross sectional asymptomatic infections was observed.

Conclusion: Adding nutritional supplements to SMC significantly increases the impact of this intervention for preventing children from malaria and other childhood infections.

Trial registration: NCT04238845.

Keywords: Malaria; Malnutrition; PlumpyDoz™; Seasonal chemo-prevention; Vitamin A; Zinc.

Fig. 1

Trial profile. Flowchart of the study participant from inclusion to the end of the follow-up period

Fig. 2

Cumulative incidence of uncomplicated malaria. Number of admissions to the health facilities due to uncomplicated malaria diagnosed clinically and confirmed by RDT per study arm form the beginning of the intervention to the end of the follow-up period. Note that each participant can contribute more than one episode of uncomplicated malaria over the study period. Blue curve represents control arm while green and red curves represent Plumpy’Doz and Zinc arm, respectively

Fig. 3

Cross-sectional RDT positivity rate per study arm. This figure displays the proportion of participants tested positive for malaria when deploying the RDT. For this, monthly visits data were used to estimate the proportions of infected participants to malaria when using RDT per study arm. Blue curve represents control arm while green and red curves represent Plumpy’Doz and Zinc arm, respectively

Fig. 4

Cumulative incidence of all cause morbidity over the study period. Number of admissions to the health facilities due to a disease regardless the type of infections per study arm form the beginning of the intervention to the end of the follow-up period. Blue curve represents control arm while green and red curves represent Plumpy’Doz and Zinc arm, respectively. Note that each participant can contribute more than one episode of all cause morbidity over the study period