Impact of Oral Nutritional Supplement on Growth, Nutrient Intake and Frequency of Illness in Children aged 4-6 Years: A Randomised Controlled Study
Published: November 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/49599.15605
Anuradha Khadilkar, Ashish Dhongade, Neha Agrawal
1. Senior Research Officer, Department of Paediatric Endocrinology, Jehangir Clinical Development Centre Pvt Ltd, Jehangir Hospital Premises, Pune, Maharashtra, India.
2. Paediatric Consultant, Department of Paediatric, Sant Dnyaneshwar Medical Education Research Centre, Pune, Maharashtra, India.
3. Assistant Manager, Department of Medical Affairs, Danone, Phoenix Market City Mumbai, Maharashtra, India
Correspondence
Dr. Anuradha Khadilkar,
Jehangir Clinical Development Centre Pvt Ltd, Jehangir Hospital Premises,
32 Sassoon Road, Pune, Maharashtra, India.
E-mail: anuradhavkhadilkar@gmail.com
Introduction: 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-ofStudy (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.
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