Comparing Compliance and Efficacy of Isocaloric Oral Nutritional Supplementation Using 1.5 kcal/mL or 1 kcal/mL Sip Feeds in Mildly to Moderately Malnourished Indonesian Children: A Randomized Controlled Trial

Abstract

PurposeThis study set out to evaluate the compliance to, and efficacy of oral supplementation, using a 1.5 kcal/mL or 1 kcal/mL sip feed, in children with mild to moderate malnutrition.MethodsThis was a parallel, randomized, controlled open-label trial in children aged 3 to 6 years with a weight for height Z (WHZ) score <−1 and ≥−3, who were randomized to receive a total of 600 kcal/day from either a 1.5 kcal/mL or a 1.0 kcal/mL pediatric sip feed for 28 days. Assessments included daily study product intake, body weight, tolerance and dietary intake from solid food.ResultsOf 110 children recruited, 98 (mean±standard deviation of age 49±7 months) completed the study. Both sip feeds were well tolerated, with high compliance (80±24% and 81±22% of prescribed volume in 1.5 kcal/mL and 1.0 kcal/mL groups respectively, p=0.79). Both study groups gained similar weight during the 28 days intervention period (0.42±0.40 kg in 1.5 kcal/mL group vs. 0.49±0.49 kg in 1.0 kcal/mL group, p=0.43). There were no significant differences between the groups in weight gain and in the change in WHZ score over the intervention period. Dietary analysis at the end of the study did not show replacement of solid food by the oral nutritional supplements.ConclusionIn children with mild to moderate malnutrition, both 1.5 kcal/mL and 1 kcal/mL pediatric sip feeds had high compliance and were well tolerated, and were equally effective in promoting weight gain in the 28 days study period.

Nutritional status and function after high-calorie formula vs. Chinese food intervention in undernourished children with cerebral palsy

“…There were no significant differences between the groups with regard to the incidence rate of gastrointestinal symptoms, suggesting that the high-calorie formula was well tolerated among children with CP. It is in accordance with the earlier studies ( 37 , 38 ).…”

Oral nutritional supplementation with dietary counseling improves linear catch-up growth and health outcomes in children with or at risk of undernutrition: a randomized controlled trial

“…Overall, these findings support the safety and tolerance of the study ONS intervention (i.e., ONS + DC). The rates of GI tolerance AEs reported in the current study were comparable in type and incidence to those found in other studies investigating ONS in undernourished children ( 86 , 87 ).…”

Effect of high-calorie formula on weight, height increment, IGF-1 and TLC in growth faltering children: A quasi-experimental study

“…This was distributed as follows: 600 kcal from solid food and 400 kcal prescribed through the ONS. The utilization of an ONS proves beneficial in enhancing the dietary intake and nutritional status of children facing challenges in meeting their nutritional needs solely through regular foods [ 2 , 21 , 34 , 35 ]. Our subjects’ calorie deficit was equivalent to 400 kcal, therefore it is reasonable to supply as much as 400 kcal/day of additional calorie intake through ONS intervention to meet their calorie requirements, with 100 kcal taken four times a day.…”