Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 24-hour systolic blood pressure (24h SBP)
研究概览
简要总结
In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension, particularly in African Americans (AA). Key components of such a diet are potassium, magnesium, and alkali, each of which has been implicated in lowering blood pressure. In the original IND 116,208, the investigators explored whether potassium-magnesium citrate (KMgCit) as a powder pharmaceutical formulation (dissolved in water before ingestion) could serve as a surrogate for the DASH diet and would lower blood pressure among patients with pre- or Stage I hypertension. Unfortunately, previous studies did not include adequate number of African American patients.
详细描述
This is a double blind, randomized crossover trial comprising two phases: Placebo Phase (microcrystalline cellulose in water) and KMgCit Phase (KMgCit powder in water) to investigate the use of KMgCit in lowering blood pressure and reducing arterial stiffness. One half of the subjects will undergo the Placebo phase first followed by the KMgCit phase. The other half will undergo the KMgCit phase first followed by the Placebo phase. Each phase is 4 weeks in duration with at least 1 week washout between phases.
Forty-five African American patients of either sex with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic of < 90 mmHg according the 2017 ACC/AHA high BP guideline, will be recruited into the trial, with the expectation that 36 patients would complete both phases of the trial (assuming 20% dropout). They may be AA adult men or women (> 21 years of age). They may be on ACE inhibitor or ARB, but not on spironolactone or diuretic. Excluded will be patients with diabetes mellitus, renal impairment, heart disease, chronic NSAID use, gastrointestinal reflux disease requiring treatment with acid reducing agent of antacid more than once a week, esophageal-gastric ulcer, chronic diarrhea, hyperkalemia, abnormal liver function test, subjects who require potassium supplementation on a regular basis for any reason, pregnancy, history of major depression, bipolar disorder or schizophrenia, and history of substance abuse
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study supplement will be dispensed in a blinded manner.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American patients with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic BP of < 90 mmHg.
排除标准
- •Diabetes mellitus,
- •Renal impairment (serum creatinine > 1.4 mg/dL),
- •Any heart diseases such as congestive heart failure or sustained arrhythmia,
- •Chronic NSAID use,
- •Treatment with diuretics, including spironolactone
- •Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agent or antacid more than once a week,
- •Esophageal-gastric ulcer,
- •Chronic diarrhea,
- •Hyperkalemia (serum K > 5.0 mmol/L),
- •Abnormal liver function test (AST or ALT above upper limit of normal range),
- •Subjects who require any potassium supplement on a regular basis for any reason,
- •Pregnancy,
- •History of major depression, bipolar disorder, or schizophrenia, and
- •History of substance abuse.
研究组 & 干预措施
Potassium Magnesium Citrate (KMgCit) first then Placebo
Patients will be asked to take KMgCit ( Sterling Pharmaceutical Services) first for 4 weeks. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day. Then, subjects will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks
干预措施: KMgCit (Drug)
Potassium Magnesium Citrate (KMgCit) first then Placebo
Patients will be asked to take KMgCit ( Sterling Pharmaceutical Services) first for 4 weeks. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day. Then, subjects will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks
干预措施: Placebo (Drug)
Placebo first then KMgCit
Patients will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. Then, subjects will be asked to take KMgCit (Sterling Pharmaceutical Services, Dupo, IL) after dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks
干预措施: KMgCit (Drug)
Placebo first then KMgCit
Patients will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. Then, subjects will be asked to take KMgCit (Sterling Pharmaceutical Services, Dupo, IL) after dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
24-hour systolic blood pressure (24h SBP)
时间窗: 4 weeks
24-hour blood pressures will be recorded using the Spacelab ambulatory oscillometric blood pressure monitor (ABPM) (Spacelabs Medical, Issaquah, WA). Recordings will be made every 20 minutes during the day and every 30 minutes at night. Average data will be calculated for each patient and reported as mmHg.
次要结局
- central systolic blood pressure (cSBP)(4 weeks)
- pulse wave velocity(4 weeks)
- augmentation index(4 weeks)
- klotho(4 weeks)
- FGF23(4 weeks)
研究者
Wanpen Vongpatanasin
Professor of Medicine
University of Texas Southwestern Medical Center