Statistical considerations
SD
REGRESSION, SECONDARY
Assuming dropout rate of 10%, a sample size of 80 participants (40 in either group) was required to detect absolute difference of 3% in % TSAT [standard deviation (SD) ± 4.5%] between the two groups with 80% power and two sided α of 0.05. All participants with non-missing outcome data were included in the analysis. Descriptive statistics were used to describe characteristics of study participants. Data were presented as mean ± SD or median (interquartile range, IQR) as appropriate. For baseline measurements, continuous variables were compared by independent sample t test if normally distributed, or Mann–Whitney U test if distribution were skewed. Categorical variables were analyzed by Chi-squared test or Fisher exact test as appropriate. We used linear mixed effect model as primary analysis to assess the difference in change in concentrations of primary and secondary outcomes over the study period between the 2 groups. Group (OD and BD), follow up time (week), sex and baseline concentration (value) were defined as fixed effects and study participants as random effects. Simple linear regression was modelled for those parameters which were measured at baseline and 12 weeks (IL-6 and hepcidin). P-values < 0.05 were considered statistically significant. Logarithmic transformation was used before fitting linear mixed effects model or simple linear regression model for following parameters: serum ferritin, %HYPO-He, TIBC, serum IL-6 and serum hepcidin.