Statistical analysis
malaria, parasitaemia, stunting
MALARIA, REGRESSION
With the sample size of 210 participants allocated to each group, the original trial possessed an 85% likelihood of detecting significant contrasts in severe stunting rates. This was achieved while maintaining a two-sided Type I error of 5%, even with a potential 10% drop in participants due to attrition during the follow-up period. Additionally, the exclusion of individuals who were already severely stunted at the outset (as per the initial enrolment criteria) accounted for 5% of the sample. The proportion of positive malaria parasitaemia DBS samples by intervention group at enrollment, at 9, 12, 15, and 18 months was calculated separately, and for all intervention time points combined (9–18 months). All randomized participants were eligible to be included in the analyses, with the exception that subjects with missing data on an outcome variable were excluded from the analysis of that outcome. The modified Poisson regression with a robust variance estimator was used to estimate the prevalence ratio (PR) [Null hypothesis of no difference between groups was rejected if P < 0.05. Wald’s test was used to test the global null hypothesis of no differences between the control group and the intervention groups, and the pairwise comparisons. For pairwise comparisons with P < 0.05, the hypothesis of no difference between groups was rejected only if the global null-hypothesis was also rejected.The main analysis was conducted with covariate adjustments. Covariates used in the adjusted models were derived from a predefined list of variables that could modify the prevalence of malaria parasitaemia. The covariate selection with modified Poisson regression models was performed. All the models were adjusted for the same set of covariates, which were malaria parasitaemia at enrolment, season of DBS sample collection, study site, and household asset Z-score.A sensitivity analysis was performed by combining children in the soy- and milk-LNS groups and compared it to the control group at any time of study visit to validate the association between LNS and the prevalence of asymptomatic malaria.