Impact of Oral Nutritional Supplement on Growth, Nutrient Intake and Frequency of Illness in Children aged 4-6 Years: A Randomised Controlled Study

Protein-Energy Malnutrition (PEM) and prevalence of under-weight children in India, is an important health concern. Aim: To evaluate the effect of Oral Nutritional Supplement (ONS) on growth, overall nutrient intake and frequency of illness in nutritionally at-risk Indian children. Materials and Methods: In this prospective, randomised, gender-stratified, controlled, parallel group, open label study, 216 children (aged 4-6 years with weight-for-age z-score between -2 and -1) were randomised (1:1) to receive either 45 g of ONS {Test product+Dietary advice (T+D)} or control group {Dietary advice only (D-only)} for three months. Primary endpoints included weight-for-age z-score and weight gain in terms of g/kg/day from baseline to three months. Secondary endpoints included change in height-for-age z-scores; frequency of illness, change in dietary nutrient intake and Protein/Energy (P/E) ratio from baseline through three months. Safety endpoint included Adverse Events (AEs). PROC MIXED was used to perform Repeated Measures Analysis Of Variance (RMANOVA) based on the changes in z-scores. The z-scores changes within the group from baseline to the end of three months End-of- Study (EOS) were compared using paired t-test. Results: At baseline, the mean (SD) weight-for-age z-scores were similar in both the groups {1.50 (0.309) and -1.49 (0.312) in T+D and D-only groups, respectively}. At the EOS, only T+D group showed significant mean (SD) change from baseline in weight-for-age z-score compared to the D-only group {0.59 (0.296), p<0.001 vs. 0.04 (0.267), p=0.0974}. Mean rate of weight gain (g/kg/day) was significantly higher in T+D group vs. D-only group (1.12 vs. 0.26, p<0.0001). At baseline, height-for-age z-scores were similar in both the groups {-1.36 (0.668) vs -1.37 (0.638) in T+D and D-only groups, respectively}. At EOS, the mean (SD) change from baseline in height-for-age z-score was -0.02 (0.198), p=0.2389 in T+D group and -0.15 (0.171), p<0.001 in the D-only group. However, the change was not proportionate to weight-for-age z-score. Total absolute number of illness episodes was less in T+D group vs. D-only group (9 vs. 13). Improvement in dietary nutrient intake (carbohydrate, fat, protein and energy) and P/E ratio was significantly higher (p<0.001) in T+D group vs. D-only group. Overall, 8.3% children in T+D group experienced at least one treatment-emergent AE. Conclusion: The ONS helps to improve growth, nutrient intake and reduces frequency of illness in nutritionally at-risk children.