Gastrointestinal Tolerance and Refeeding Syndrome in Severely Malnourished Children Treated with Oral Nutrition Supplements Compared to F-75/F-100: A Hospital-Based Randomized Controlled Pilot Trial

口服营养补充剂与F-75/F-100治疗重度营养不良儿童的胃肠道耐受性和再喂养综合征:一项基于医院的随机对照试点试验

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Abstract

PURPOSE: Current World Health Organization guidelines recommend F-75/F-100 for inpatients and ready-to-use therapeutic foods (RUTF) for outpatients with severe acute malnutrition (SAM). In Indonesia, F-100 continues to be administered after discharge because of limited evidence of RUTF's acceptability and effectiveness in a local setting. Home-prepared F-100 carried the risk of improper mixing and bacterial contamination. Therefore, ready-to-drink oral nutritional supplements (RTD ONS) may serve as alternatives to F-75/F-100. This study aimed to investigate the safety and effectiveness of ONS in hospitalized children with SAM. METHODS: This study was a pilot randomized controlled trial comparing the gastrointestinal tolerance of F-75/F-100, high-energy ONS, and standard-energy ONS in 108 hospitalized subjects aged 12-60 months old with complicated SAM. Subjects were monitored for gastrointestinal symptoms and refeeding syndrome. RESULTS: The incidence of vomiting due to the formula was not significantly different among the three groups (p=0.362), as was the incidence of diarrhea, which was 13.9% (F-75/F-100), 16.7% (high-energy ONS), and 11.1% (standard-energy ONS) (p=0.939). The incidences of refeeding syndrome were 13.9%, 5.6%, and 2.8% in the F-75/F-100, standard-energy ONS, and high-energy ONS groups, respectively (p=0.169). The high-energy ONS showed the highest weight increment (8.5±3.2 g/kg/day) among the three groups. CONCLUSION: Ready-to-drink ONS is a safe and effective therapeutic nutritional option for children with complicated SAM who live in areas with poor sanitation. This study provides preliminary results and requires further investigation to address the limitations of a small sample size and short study timeframe.

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