Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.
Primary Health Tasmania, Hobart, TAS, 7000, Australia.
Eur J Nutr. 2020 Aug;59(5):2183-2193. doi: 10.1007/s00394-019-02067-5. Epub 2019 Jul 31.
To assess the efficacy and safety of F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management in the rehabilitation phase of severe acute malnutrition (SAM) of infants aged under 6 months (u6m).
Double-blind randomized clinical trial was conducted to assess the efficacy and safety of F-100, F-100D, and IF at the Nutrition Rehabilitation Unit, icddr,b. Infants (n = 153) u6m with SAM were enrolled and randomly assigned to any of the three diets after stabilization. Two ml blood was collected on study days 1, 3, and 7 for measuring serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio. Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL) were calculated. Infants were discharged when gained 15% of the admission bodyweight or had edema-free weight-for-length Z-score ≥ - 2.
Infants fed F-100 and F-100D had higher weight gain than infants who received IF. Mean difference between F-100 and IF was 4.6 g/kg/d (95% CI 1.5-7.6, P = 0.004) and between F-100D and IF was 3.1 g/kg/d (95% CI 0.6-5.5, P = 0.015). Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case). RSL was highest in infants fed F-100 but serum sodium showed no sign of elevation. Urinary specific gravity and serum sodium values were within normal range.
F-100 can be safely used in the rehabilitation phase for infants u6m with SAM and there is no need to prepare alternative formulations.
评估 F-100、稀释 F-100（F100D）和婴儿配方食品（IF）在 6 个月以下（u6m）重度急性营养不良（SAM）婴儿康复阶段的饮食管理中的疗效和安全性。
在 icddr,b 的营养康复科进行了一项双盲随机临床试验，以评估 F-100、F100D 和 IF 的疗效和安全性。将患有 SAM 的 u6m 婴儿（n=153）纳入研究，并在稳定后随机分配到三种饮食中的任何一种。在研究第 1、3 和 7 天采集 2ml 血样，用于测量血清电解质、肌酐和渗透压，采集尿样用于比重和渗透压肌酐比。计算肾脏溶质负荷（RSL）和潜在肾脏溶质负荷（PRSL）。当婴儿获得入院体重的 15%或水肿消退体重-长度 Z 评分≥-2 时，婴儿即可出院。
与接受 IF 的婴儿相比，喂养 F-100 和 F100D 的婴儿体重增加更多。F-100 与 IF 之间的平均差异为 4.6g/kg/d（95%CI 1.5-7.6，P=0.004），F-100D 与 IF 之间的平均差异为 3.1g/kg/d（95%CI 0.6-5.5，P=0.015）。与其他两种饮食相比，喂养 F-100 的婴儿从研究饮食和母乳中获得的总能量摄入明显更高（每种情况下 P=0.001）。喂养 F-100 的婴儿的 RSL 最高，但血清钠没有升高的迹象。尿比重和血清钠值均在正常范围内。
F-100 可安全用于 u6m 患有 SAM 的婴儿的康复阶段，无需制备替代配方。
