TRIALS OF HYPERTENSION PREVENTION (TOHP) PHASE II

我们建议成为临床试验的临床中心 高血压的预防。在第一阶段，I-A和B， 在这项临床试验中，我们建议测试短小和 口服降压药的中期降压效果 单独补充钙、镁和omega-3脂肪酸 代理，以双重组合和所有三个组合为 与安慰剂对照组相比，在患有高血糖的人中 正常的舒张压。 我们计划招收年龄在25到45岁之间的男性 年龄在35岁到50岁之间的女性，有舒张期血液 未接受治疗的血压在78至89毫米汞柱之间 服用治疗高血压的药物。 这项研究的理论基础是基于动物实验， 相关的临床和流行病学证据 这些微量营养素对血压有影响。其他目前的研究 在我们部门和课题组正在测试疗效 减少钠，增加钾，减轻体重， 以及减少酒精摄入量和压力管理 血压的降低。这项研究将测试其他 可能有效的非药理学方法。这个 设计是一项补充试验，它将检查 在饮食基本不变的情况下，只有一种营养素。 该方法最大限度地减少了遵从性困难的类型 在主要的营养干预研究中遇到 需要修改饮食，并允许将重点放在 中枢单一营养素假说。设计也可能是 双目失明。 血压的变化将是主要的结果衡量标准 调查过了。我们还将调查 对特定营养补充剂有反应者和无反应者 和补充剂组合。 我们建议在第一阶段测试这些干预措施， 并测量依从性和副作用。我们计划工作 与其他团体和NIH工作人员密切合作。我们也会是 愿意根据委员会的决定修改提案 试验指导委员会，包括测量 其他营养素。

We propose to be a clinical center for the Clinical Trials of Hypertension Prevention. In the first Phase, I-A and B, of this clinical trial we propose to test the short and intermediate term blood pressure lowering efficacy of oral calcium, magnesium and omega-3 fatty acid supplement as single agents, in dual combination and all three in combination as compared to a placebo control group, in persons with high normal diastolic blood pressures. We plan to enroll males between the ages of 25 to 45 and females between the ages of 35 and 50 with a diastolic blood pressure of between 78 and 89mm Hg who are not being treated with drugs for hypertension. The rationale for the study is based on animal experimental, clinical and epidemiological evidence for the association of these micronutrients on blood pressure. Other current studies in our Department and research group are testing the efficacy of sodium reduction, potassium increase and weight reduction, as well as decreased alcohol intake and stress management in the reduction of blood pressure. This study would test other non-pharmacological approaches which may be effective. The design is a supplement trial which will examine the increase in a single nutrient with the diet essentially being unchanged. The appoach minimizes the type of compliance difficulties encountered in major nutrient intervention studies which require dietary modifications and allow for a focus on a central single nutrient hypothesis. The design also may be double blinded. Changes in blood pressure will be the primary outcome measure investigated. We will also be investigating characteristics of responders and non-responders to particular nutrient supplement and supplement combinations. We propose during the first phase to test these interventions, and to measure adherence and side effects. We plan to work closely with other groups and the NIH staff. We also would be willing to modify the proposal based on the decisions of the Steering Committee of the Trial including the measurements of other nutrients.