Retrospective chart reviews have reported hypophosphatemia associated with elemental formula use in infants and children with systemic disease involving multiple diagnoses. The present study aims to evaluate the bioavailability of phosphorus from 2 commercial elemental formulas and to test our hypothesis of bioequivalence of the 2 products in healthy volunteers receiving gastric acid-suppressive medication. A single-center, double-blind, randomized, cross-over study was conducted in healthy volunteers with esomeprazole-induced hypochlorhydria. After a standardized low phosphorus meal followed by overnight fasting, subjects consumed 1 gram of phosphorus in a single oral dose of 1217 kcal of Product A (Neocate) or Product B (Elecare). The alternate product was given following a 1-week washout period. Blood and urine were collected at baseline and different time-points for up to 6 hours after product consumption. Area-under-the-curve (AUC) and peak values (Cpeak) for serum phosphate and calcium and urinary creatinine-corrected phosphate and calcium were assessed for bioequivalence of Products A and B. Results show that the geometric mean ratio (GMR) and 90% CI for serum phosphate were 1.041 (0.998-1.086) and 1.020 (0.963-1.080) for AUC0-360 and Cpeak, respectively, meeting the predetermined criteria for bioequivalence. Urinary creatinine-corrected phosphate followed a similar pattern after intake of Product A and B, but did not reach bioequivalence criteria (GMR: AUC70-370 = 1.105 (0.918-1.330); Cpeak = 1.182 (1.040-1.343)). Serum calcium concentrations (GMR: AUC0-360 = 1.002 (0.996-1.009); Cpeak = 0.991 (0.983-0.999)) and urinary creatinine-corrected calcium excretion (GMR: AUC70-370 = 1.117 (1.023-1.219); Cpeak = 1.157 (1.073-1.247)) demonstrated bioequivalence of the products. In conclusion, both elemental infant formulas showed equivalent serum phosphorus and calcium bioavailability in healthy volunteers even if combined with treatment with acid-suppressive medication.

中文翻译：

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不同元素婴儿配方奶粉在健康志愿者中显示出相同的磷和钙生物利用度

回顾性图表审查报告了与婴儿和儿童使用基本配方奶粉相关的低磷血症，涉及多种诊断的全身性疾病。本研究旨在评估 2 种商业元素配方中磷的生物利用度，并测试我们关于这两种产品在接受胃酸抑制药物治疗的健康志愿者中生物等效性的假设。一项单中心、双盲、随机、交叉研究在患有埃索美拉唑诱发的胃酸过少的健康志愿者中进行。在标准的低磷餐和隔夜禁食后，受试者在单次口服剂量为 1217 kcal 的产品 A (Neocate) 或产品 B (Elecare) 中消耗了 1 克磷。在 1 周的洗脱期后给予替代产品。在产品消耗后长达 6 小时的基线和不同时间点收集血液和尿液。评估了产品 A 和 B 的生物等效性的血清磷酸盐和钙以及尿肌酐校正磷酸盐和钙的曲线下面积 (AUC) 和峰值 (Cpeak)。结果显示几何平均比 (GMR) 和对于 AUC0-360 和 Cpeak，血清磷酸盐的 90% CI 分别为 1.041 (0.998-1.086) 和 1.020 (0.963-1.080)，符合预定的生物等效性标准。摄入产品 A 和 B 后，尿肌酐校正磷酸盐遵循类似的模式，但未达到生物等效性标准（GMR：AUC70-370 = 1.105 (0.918-1.330)；Cpeak = 1.182 (1.040-1.343)）。血清钙浓度（GMR：AUC0-360 = 1.002 (0.996-1.009)；Cpeak = 0.991 (0.983-0. 999)) 和尿肌酐校正的钙排泄（GMR：AUC70-370 = 1.117 (1.023-1.219)；Cpeak = 1.157 (1.073-1.247)）证明了产品的生物等效性。总之，即使与抑酸药物联合治疗，两种基本婴儿配方奶粉在健康志愿者中显示出相同的血清磷和钙生物利用度。