| dc.description.abstract | Background The high prevalence of micronutrient deficiencies among South African preschool children reinforces the need for an intensified micronutrient malnutrition control strategy targeting children at home or in school. The use of recently developed micronutrient powders also known as "in-home fortification" or "point-of-use fortification" can be an effective long-term, sustainable approach in improving early childhood nutrition and cognitive developmental potential. However, before embarking on large-scale, long-term, point-of-use fortification trials, it is imperative to conduct external pilot trials in which the feasibility of implementing full-scale studies can be effectively assessed. Objective The objective of this study was to assess the feasibility of implementing a point-of-use micronutrient fortification trial among African preschool children, which would aid in pilot-testing the study design, logistics and implementation process as well as reveal limitations which can be addressed before the implementation of full-scale trials. Methods Preschool children (n = 151), aged 36 -79 months with haemoglobin concentration (Hb)<= 12.5 g/dL, from eight schools in a low socio-economic community were randomly assigned to an intervention (n = 76) and a control (n = 75) groups, both receiving breakfast maize-meal porridge, either with added micronutrient or placebo powder for 52 school days. Several process evaluation indicators (fidelity, dose delivered, dose received, reach, recruitment and context) were used to assess trial feasibility. Selected indicators of early childhood development (Hb concentration, anthropometric indices and cognitive function) were used to evaluate the outcome of the intervention within the context of a pilot study. Results The process evaluation results indicate that the various implementation components were delivered with high fidelity. Capacity development and strengthening of the front-line staff cognitive assessors and study assistants) was executed as planned. The point-of-use fortificant was well accepted among the children and the mean percentage of days the point-of-use fortificant or placebo was consumed (~85%) did not differ between the groups. There were significant increases in Hb concentration (p < 0.05) from baseline to follow-up in both the intervention [mean change: 0.38 g/dL (95% CI: 0.14, 0.61 g/dL)] and control [mean change: 0.57 g/dL (95% CI: 0.35, 0.80 g/dL)] groups, however, mean change did not differ significantly between the groups (p = 0.250). The intervention did not improve any of the anthropometric indices measured in the intervention group compared to control. However, there was a medium likelihood for practical significance for the two global cognitive scores assessed, nonverbal index [intervention effects: 7.20 (95% C!: 2.60,11.81); P = 0.002, effect size: 0.55] and mental processing index [intervention effects: 2.73 (95% CI: 0.25,5.70); P = 0.072, effect size: 0.36] on the Kaufman Assessment Battery for Children, second edition. Conclusion The feasibility of implementing a point-of-use micronutrient fortification trial was demonstrated among African preschool children with potential benefits of improving their cognitive function. The most important lessons learned from this trial that could help improve similar future large-scale trials included the recruitment and training of the most eligible front-line staff as well as identifying that the use of a simple field-friendly finger prick method to measure Hb concentration may not be sufficiently sensitive to show differences in iron status after the intervention. | |
