Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Department of General, Analytical and Physical Chemistry, Montanuniversität Leoben, Franz-Josef-Straße 18, 8700, Leoben, Austria.
Sci Rep. 2021 Jul 20;11(1):14796. doi: 10.1038/s41598-021-94245-x.
Lead exposure can cause substantial organ damage. Enteral lead absorption may be reduced by concomitant intake of clinoptilolite tuff, a zeolite from natural sources. This study aimed to assess the effect of purified clinoptilolite tuff (G-PUR) on enteral lead uptake in adults using stable lead isotope Pb as a tracer. In this randomized, placebo-controlled, double-blind, parallel-group study, 42 healthy participants were randomized to receive oral G-PUR 2.0 g, 2 * 2.0 g, or placebo, together with 2.5 µg of Pb in water. The enrichment of Pb caused by the tracer in blood and urine was measured by mass spectrometry. G-PUR was well tolerated. The mean maximum Pb enrichment of 0.505% of total blood lead was significantly higher (p < 0.0001) in the placebo group compared to G-PUR 2.0 g (0.073%) or G-PUR 2 * 2.0 g (0.057%) group. Normalized Pb AUC was 86.5, 11.9, and 8.5% * h without and with G-PUR 2.0 g, and G-PUR 2 * 2.0 g, respectively (p < 0.0001 vs. placebo). This smaller Pb exposure was paralleled by a reduced urinary excretion in subjects receiving G-PUR. Concomitant oral intake of purified clinoptilolite tuff reduced enteral uptake of Pb in healthy humans by approximately 90%. The reduced bioavailability is demonstrable by a decrease of Pb tracer enrichment in blood and urine.Trial registration: clinicaltrials.gov identifier: NCT04138693, registered 24/10/2019.
铅暴露可导致实质性器官损伤。同时摄入天然来源的沸石——斜发沸石,可能会减少经肠道吸收的铅。本研究旨在评估用稳定的铅同位素 Pb 作为示踪剂,评估纯化斜发沸石(G-PUR)对成年人经肠道摄取铅的影响。在这项随机、安慰剂对照、双盲、平行组研究中,42 名健康参与者被随机分配接受口服 G-PUR 2.0 g、2 * 2.0 g 或安慰剂,同时口服水中 2.5 μg Pb。通过质谱法测量示踪剂在血液和尿液中引起的 Pb 富集。G-PUR 耐受性良好。与 G-PUR 2.0 g(0.073%)或 G-PUR 2 * 2.0 g(0.057%)组相比,安慰剂组血液中总血铅的 Pb 最大富集平均值 0.505%明显更高(p < 0.0001)。未服用和服用 G-PUR 2.0 g、G-PUR 2 * 2.0 g 时,Pb AUC 的归一化值分别为 86.5、11.9 和 8.5% * h(p < 0.0001 与安慰剂相比)。G-PUR 组的 Pb 暴露量减少,相应的尿液排泄量也减少。健康人群同时口服纯化斜发沸石可减少经肠道摄取的铅,约 90%。通过减少血液和尿液中 Pb 示踪剂的富集,可证明其生物利用度降低。试验注册:ClinicalTrials.gov 标识符:NCT04138693,于 2019 年 10 月 24 日注册。