NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes
NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes
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DOI：
10.1080/02652030701458105
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发表时间：
2008-01-01
影响因子：
2.9
通讯作者：
Phillips, T. D.
中科院分区：
文献类型：
--
作者：
Afriyie-Gyawu, E.;Ankrah, N. -A.;Phillips, T. D.
在加纳进行了一项为期3个月的双盲和安慰剂对照的IIa期临床试验，以研究膳食NovaSil（NS）的安全性、耐受性和黄曲霉毒素吸附功效。志愿者（507名受试者）进行临床筛选，以评估他们的一般健康状况，妊娠状况和血液AFB（1）-白蛋白加合物水平。在这些受试者中，177名被随机分配到三个组：高剂量（HD）、低剂量（LD）和安慰剂对照（PL）组，每天（-1）接受3.0、1.5和0 g NS胶囊。经过培训的研究监查员监督参与者接受NS胶囊给药，并每天记录副作用。每月进行一次体格检查。采集血液和尿液样本进行实验室分析。大约92%的参与者（177人中的162人）完成了研究，依从率超过97%。总体而言，99.5%的人x时间报告在整个研究中没有副作用。一些参与者记录了轻度至中度健康事件（类似于0.5%的人x时间）。症状包括恶心、腹泻、胃灼热和头晕。这些副作用在所有三组中统计学上相似。三组间血液学、肝肾功能和电解质无显著差异。这些发现表明，NS粘土显然是安全和实用的保护人类免受黄曲霉毒素在人群中的黄曲霉毒素中毒的高风险。
A 3-month double-blind and placebo-controlled, phase IIa clinical trial was conducted in Ghana to investigate the safety, tolerance and aflatoxin-sorption efficacy of dietary NovaSil (NS). Volunteers (507 subjects) were clinically screened to evaluate their general health, pregnancy status and blood AFB(1)-albumin adduct levels. Of these subjects, 177 were randomly assigned to three groups: high-dose (HD), low-dose (LD) and placebo-control (PL) groups receiving 3.0, 1.5 and 0 g NS day(-1) in capsules. Trained study-monitors supervised NS capsule administration to participants and recorded side-effects daily. Physical examinations were performed monthly. Blood and urine samples were collected for laboratory analysis. Approximately 92% of the participants (162 of 177) completed the study and compliance rate was over 97%. Overall, 99.5% of person x time reported no side-effects throughout the study. Mild to moderate health events (similar to 0.5% of person x time) were recorded in some participants. Symptoms included nausea, diarrhea, heartburn and dizziness. These side-effects were statistically similar among all three groups. No significant differences were shown in hematology, liver and kidney function or electrolytes in the three groups. These findings demonstrate that NS clay is apparently safe and practical for the protection of humans against aflatoxins in populations at high risk for aflatoxicosis.