Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Elevated Systolic Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in seated diastolic blood pressure from baseline to 12 weeks
研究概览
简要总结
The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation for 12 weeks lowers blood pressure.
详细描述
This clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 120 adults aged 30-74 who have a systolic blood pressure of 130-154 mmHg.
Eligibility to participate in the trial will be determined by a 2-stage screening process. Interested participants will complete a pre-screening form online. If eligibility criteria are met, the potential participants will be scheduled for an in-person screening clinic visit. At the visit, eligible participants will be reminded about the study details and potential risks and will be given the opportunity to sign the Informed Consent. Consented participants will be assigned by chance (like a coin toss) to daily magnesium or to placebo. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening) for 12 weeks.
Assessments at the screening visit include seated blood pressure; pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for a clinic visit at 12 weeks to assess these measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-report of systolic blood pressure 125-159 mmHg
- •Measured seated systolic blood pressure 130-159 mmHg at screening visit
- •Body mass index less than 40 kg/m2
- •Total magnesium intake from supplements of no more than 100 mg/day
- •Willing to maintain current diet and supplement use patterns during the 12-week intervention period
排除标准
- •Measured seated diastolic blood pressure 100 mmHg or greater at screening visit
- •Antacid or laxative use 4 times/week or more within the past 3 months
- •History of cardiovascular disease (myocardial infarction, stroke, revascularization [coronary artery bypass graft or percutaneous transluminal coronary angioplasty], or angina pectoris)
- •History of invasive cancer diagnosed within the last 5 years (non-melanoma skin cancer permitted)
- •History of type 1 or 2 diabetes
- •History of renal disease
- •History of kidney failure
- •History of dialysis
- •History of pancreatitis
- •History of inflammatory bowel disease
- •History of hypermagnesemia
- •Women who are pregnant, nursing, or intend to become pregnant during the period of treatment
- •Plan to relocate out of Boston area within the next year
- •Unwillingness and/or inability to swallow 4 pills per day
- •Inability to provide written informed consent
研究组 & 干预措施
placebo
placebo supplement
干预措施: placebo (Dietary Supplement)
magnesium
magnesium glycinate supplement, 480 mg/day
干预措施: magnesium glycinate supplement (Dietary Supplement)
结局指标
主要结局
Change in seated diastolic blood pressure from baseline to 12 weeks
时间窗: Baseline and 12 week
Change in seated systolic blood pressure from baseline to 12 weeks
时间窗: Baseline and 12 week
次要结局
- Whether the effect of magnesium on seated blood pressure is modified by baseline serum and/or RBC magnesium(Baseline and 12 week)
- Change in RBC magnesium levels from baseline to 12 weeks(Baseline and 12 week)
- Change in serum magnesium levels from baseline to 12 weeks(Baseline and 12 week)
研究者
Howard D. Sesso, ScD, MPH
Associate Epidemiologist, Associate Professor of Medicine
Brigham and Women's Hospital