Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study

Emory University

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01114373

IRB00021300a

3R21AT004509-01A2S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females ages 18 to 64
• Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) > 115mmHg))
• Taking no more than 2 antihypertensive medications
• African American (self-defined by the participant)

Exclusion criteria

• Secondary forms of hypertension
• Presence of other diseases requiring treatment with BP lowering medication
• Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or history of 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 > 1.4 mg/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 inhibitors (COX2-I), 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: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Description:

Subjects with mild to moderate essential hypertension will be given 24mg time release melatonin for 4 weeks either before or after exposure to 4 week of placebo with no washout period.

Treatment:

Drug: Melatonin

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Subjects with mild to moderate essential hypertension will be given placebo for 4 weeks either before or after exposure to 4 weeks of 24mg daily dose of time release melatonin with no washout period.

Treatment:

Drug: Melatonin

Drug: Placebo