Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | September 2014 |
Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study
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.
night for 4 weeks) on nighttime blood pressure in African Americans with a history of
elevated nighttime blood pressure.
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
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