Kumi Justice, Appiah-Opong Regina, Rein Dietrich, Egbi Godfred, Aninagyei Enoch, Boye Alex, Omane-Acheampong Desmond
University of Ghana, Noguchi Memorial Institute for Medical Research, Legon, Accra, Ghana.
University of Cape Coast, Department of Biomedical Science, Cape Coast, Ghana.
Glob Pediatr Health. 2022 Sep 16;9:2333794X221121243. doi: 10.1177/2333794X221121243. eCollection 2022.
. Aflatoxin levels are very high in animals and humans in places where cereals are poorly stored. In this study, Novasil was evaluated for safety and efficacy in children. Children (200) aged between 2 and 9 years were put into Novasil and placebo group. Participants received either 1.5 g of Novasil or calcium carbonate in their food. Urine samples were analyzed for AFM1 by HPLC, blood samples were assayed for complete blood count and chemistries. Aflatoxin M1 levels in the Novasil treated group, significantly reduced to 60% compared to an increase of urine AFM1 in the placebo group. Hematological parameters did not change except for an increase in hemoglobin level in the Novasil group. Biochemical parameters remained unchanged except calcium ions. Glutathione levels in the Novasil increased, compared group to the placebo group. Novasil is safe, reduce aflatoxin bioavailability in humans while improving GSH antioxidant capacity as well. The trial has been registered with Pan African Clinical Trial Registry (www.pactr.org). A WHO registry for clinical trials with a unique identification number PACTR202202797930675.
在谷物储存条件差的地区，动物和人类体内的黄曲霉毒素水平非常高。在本研究中，对Novasil在儿童中的安全性和有效性进行了评估。200名年龄在2至9岁之间的儿童被分为Novasil组和安慰剂组。参与者在食物中分别摄入1.5克Novasil或碳酸钙。通过高效液相色谱法分析尿液样本中的AFM1，对血液样本进行全血细胞计数和化学分析。与安慰剂组尿液中AFM1增加相比，Novasil治疗组的黄曲霉毒素M1水平显著降低至60%。除Novasil组血红蛋白水平升高外，血液学参数没有变化。除钙离子外，生化参数保持不变。与安慰剂组相比，Novasil组的谷胱甘肽水平升高。Novasil是安全的，可降低人体内黄曲霉毒素的生物利用度，同时提高谷胱甘肽抗氧化能力。该试验已在泛非临床试验注册中心（www.pactr.org）注册。世界卫生组织临床试验注册中心赋予其唯一识别号PACTR202202797930675。
