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

Emory University40 enrolled

Overview

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.

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 24mg of time release melatonin pills (3 x 8mg) to be taken orally at night for 4 weeks.

PlaceboDRUG

Subjects will receive placebo pills (3 pills) 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) \> 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.

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 are reported.

Time frame: 4 weeks

Mean Nighttime Diastolic Blood Pressure (DBP)

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 are reported.

Time frame: 4 weeks

Secondary Outcomes

Mean Nighttime Mean Arterial Pressure (MAP)

Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.

Time frame: 4 weeks

Mean Nighttime Heart Rate (HR)

Nighttime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.

Time frame: 4 weeks

Mean Daytime Systolic Blood Pressure (SBP)

The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.