Department of Pediatrics, Division of Pediatric Infectious Diseases, Rainbow Babies and Children's Hospital, Cleveland, OH.
Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.
J Acquir Immune Defic Syndr. 2019 Nov 1;82(3):275-280. doi: 10.1097/QAI.0000000000002129.
In this study, we explored the effect of zinc supplementation on markers of inflammation and monocyte activation in antiretroviral therapy-treated HIV infection.
This is a phase I open-labeled randomized double-arm study, exploring the efficacy and safety of zinc supplementation on inflammation in ≥18-year-old people living with HIV in the US, on stable antiretroviral therapy and with zinc levels ≤75 µg/dL in the last 60 days. Patients were randomized 1:1 to zinc gluconate capsules at a dose of 45 mg (low-dose), or 90 mg (high-dose) elemental zinc daily for 16 weeks. We assessed inflammatory and gut integrity biomarkers at baseline and 16 weeks.
Overall, a total of 52 participants were enrolled (25 participants in the low-dose arm and 27 participants in the high-dose arm). Median (Interquartile range) age was 49 (38, 60) years, 77% were men and 73% were African Americans. At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm. Overall, 48%-60% of participants experienced a reduction in biomarkers levels. The margin of reduction ranged between 8% and 21%. This change was meaningful with large effect size (Cohen D ranging from 5 to 19).
In this pilot study, we found that zinc supplementation is effective at increasing circulating zinc levels. In addition, our findings provide novel data suggesting that zinc can affect a biological signature in people living with HIV and modulate biomarkers associated with clinical comorbidities.
本研究旨在探讨补锌对接受抗逆转录病毒治疗的 HIV 感染患者炎症和单核细胞活化标志物的影响。
这是一项 I 期开放标签随机双臂研究,旨在探索锌补充剂对美国≥18 岁、接受稳定抗逆转录病毒治疗且过去 60 天内锌水平≤75μg/dL 的 HIV 感染者炎症的疗效和安全性。患者按 1:1 随机分为葡萄糖酸锌胶囊低剂量组(45mg,每日 1 次)或高剂量组(90mg,每日 1 次),疗程 16 周。我们在基线和 16 周时评估了炎症和肠道完整性生物标志物。
共有 52 名参与者(低剂量组 25 名,高剂量组 27 名)入组。中位(四分位距)年龄为 49(38,60)岁,77%为男性,73%为非裔美国人。基线时,中位锌水平为 73(64,86)μg/dL。低剂量组和高剂量组的循环锌中位水平分别升高至 91μg/dL 和 100μg/dL。总体而言,48%-60%的参与者的生物标志物水平降低。降幅范围为 8%-21%。这种变化具有统计学意义(Cohen D 为 5-19)。
在这项初步研究中,我们发现补锌能有效增加循环锌水平。此外,我们的研究结果提供了新的数据,表明锌可以影响 HIV 感染者的生物学特征,并调节与临床合并症相关的生物标志物。