Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study

Emory University37 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

MelatoninDRUG

Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks.

PlaceboDRUG

Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Mean Nighttime Systolic Blood Pressure (SBP)

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.