Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Mean Nighttime Diastolic Blood Pressure (DBP)
研究概览
简要总结
This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.
详细描述
The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.
The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.
Finally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ages 18 to 64
- •Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) >115 mmHg))
- •Taking no more than 2 antihypertensive medications
- •African-American race (self-defined by the participant)
排除标准
- •Secondary forms of hypertension
- •Presence of other diseases requiring treatment with BP lowering medications
- •Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and transient ischemic attacks)
- •Diabetes mellitus (type 1 or 2)
- •Cancer/Malignancy other than nonmelanoma skin cancer
- •Primary renal disease
- •Serum creatinine > 1.5 mg/dL in men or > 1.4mg/dL in women
- •Severe anemia
- •Liver enzymes > 2.5 times upper limits of normal
- •Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire
- •Current treatment with or regular use of calcium channel blocking agents, cyclooxygenase-2 or COX2-inhibitors, oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin
- •Current use of melatonin or any sleep aids containing melatonin.
- •Regular consumption (1 or more times per week) of any of the following of Vitamin methyl B12, St. Johns Wort, Feverfew, black and white mustard seeds, wolf berry seed
- •Severe Sleep apnea
- •Night work
- •Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
研究组 & 干预措施
Melatonin
African-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure).
干预措施: Melatonin (Drug)
Melatonin
African-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure).
干预措施: Placebo (Drug)
Placebo
African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)
干预措施: Melatonin (Drug)
Placebo
African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Nighttime Diastolic Blood Pressure (DBP)
时间窗: At the end of 4 weeks
The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported
Mean Nighttime Systolic Blood Pressure (SBP)
时间窗: At the end of 4 weeks
The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.
次要结局
- Mean Daytime Diastolic Blood Pressure (DBP)(At the end of 4 weeks)
- Mean Daytime Mean Arterial Pressure (MAP)(At the end of 4 weeks)
- Plasma P-Selectin(At the end of 4 weeks)
- Mean Daytime Systolic Blood Pressure (SBP)(At the end of 4 weeks)
- Mean Nighttime Mean Arterial Pressure (MAP)(At the end of 4 weeks)
- Mean Nighttime Heart Rate (HR)(At the end of 4 weeks)
- Urinary Dopamine Excretion Rate(At the end of 4 weeks)
- Urinary Noradrenaline Excretion Rate(At the end of 4 weeks)
- Mean Daytime Heart Rate (HR)(At the end of 4 weeks)
- Total Sleep Time(At the end of 4 weeks)
- Nocturnal Dipping of Blood Pressure(At the end of 4 weeks)
- Percentage of Participants With Melatonin-related Side Effect.(After 4 weeks of treatment)
- Urinary Adrenaline Excretion Rate(At the end of 4 weeks)
- Plasma E-Selectin(At the end of 4 weeks)
研究者
Frederic Rahbari-Oskoui, MD, MSCR
Associate Professor of Medicine
Emory University