Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, United States of America.
Minnesota Community Care, St. Paul, Minnesota, United States of America.
PLoS One. 2023 Feb 1;18(2):e0279830. doi: 10.1371/journal.pone.0279830. eCollection 2023.
Hmong men in Minnesota exhibit a high prevalence of gout and hyperuricemia. Although evidence of vitamin C's effectiveness as a treatment for gout is mixed, analysis of therapeutic benefit based on an individual's multiomic signature may identify predictive markers of treatment success.
The primary objective of the Hmong Microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C) study was to assess the effectiveness of vitamin C on serum urate in Hmong adults with and without gout/hyperuricemia. The secondary objectives were to assess if 1) vitamin C impacts the taxonomic and functional patterns of microbiota; 2) taxonomic and functional patterns of microbiota impact vitamin C's urate-lowering effects; 3) genetic variations impact vitamin C's urate-lowering effects; 4) differential microbial biomarkers exist for patients with or without gout; and 5) there is an association between obesity, gut microbiota and gout/hyperuricemia.
This prospective open-labelled clinical trial was guided by community-based participatory research principles and conducted under research safety restrictions for SARS-CoV-2. We aimed to enroll a convenient sample of 180 Hmong adults (120 with gout/hyperuricemia and 60 without gout/hyperuricemia) who provided medical, demographic, dietary and anthropometric information. Participants took vitamin C 500mg twice daily for 8 weeks and provided pre-and post- samples of blood and urine for urate measurements as well as stool samples for gut microbiome. Salivary DNA was also collected for genetic markers relevant to uric acid disposition.
We expected to quantify the impact of vitamin C on serum urate in Hmong adults with and without gout/hyperuricemia. The outcome will enhance our understanding of how gut microbiome and genomic variants impact the urate-lowering of vitamin C and associations between obesity, gut microbiota and gout/hyperuricemia. Ultimately, findings may improve our understanding of the causes and potential interventions that could be used to address health disparities in the prevalence and management of gout in this underserved population.
ClinicalTrials.gov NCT04938024 (first posted: 06/24/2021).
明尼苏达州的苗族男性痛风和高尿酸血症的患病率很高。虽然维生素 C 治疗痛风的有效性证据不一，但基于个体的多组学特征分析治疗益处可能会确定治疗成功的预测标志物。
苗族微生物组和痛风、肥胖、维生素 C（HMANGO-C）研究的主要目的是评估维生素 C 对有和无痛风/高尿酸血症的苗族成年人血尿酸的疗效。次要目的是评估 1）维生素 C 是否会影响微生物群的分类和功能模式；2）微生物群的分类和功能模式是否会影响维生素 C 的降尿酸作用；3）遗传变异是否会影响维生素 C 的降尿酸作用；4）有无痛风患者的微生物生物标志物存在差异；以及 5）肥胖、肠道微生物群与痛风/高尿酸血症之间是否存在关联。
本前瞻性开放标签临床试验以社区为基础的参与式研究原则为指导，并在 SARS-CoV-2 研究安全限制下进行。我们旨在招募 180 名方便抽样的苗族成年人（120 名有痛风/高尿酸血症，60 名无痛风/高尿酸血症），他们提供了医疗、人口统计学、饮食和人体测量信息。参与者每天服用维生素 C 500mg，分两次服用，共 8 周，并提供血液和尿液尿酸检测的预、后样本以及粪便样本进行肠道微生物组检测。还收集唾液 DNA 用于与尿酸处置相关的遗传标记。
我们期望量化维生素 C 对有和无痛风/高尿酸血症的苗族成年人血清尿酸的影响。该结果将增强我们对肠道微生物组和基因组变异如何影响维生素 C 降尿酸以及肥胖、肠道微生物群和痛风/高尿酸血症之间关联的理解。最终，研究结果可能会增进我们对痛风患病率和管理方面的健康差异的原因和潜在干预措施的理解，这在这一服务不足的人群中是一个亟待解决的问题。
ClinicalTrials.gov NCT04938024（首次发布：2021 年 6 月 24 日）。
