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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Melatonin; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Melatonin; 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.; Drug: Placebo; Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.
Placebo Comparator: Placebo; African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)	Drug: Melatonin; 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.; Drug: Placebo; Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of 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 were reported	At the end of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 were reported	At the end of 4 weeks
Mean Nighttime Heart Rate (HR)	Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported	At the end of 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 were reported	At the end of 4 weeks
Mean Daytime Diastolic Blood Pressure (DBP)	The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported	At the end of 4 weeks
Mean Daytime Mean Arterial Pressure (MAP)	Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. 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 were reported.	At the end of 4 weeks
Mean Daytime Heart Rate (HR)	Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported	At the end of 4 weeks
Urinary Dopamine Excretion Rate	The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.	At the end of 4 weeks
Urinary Noradrenaline Excretion Rate	The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.	At the end of 4 weeks
Urinary Adrenaline Excretion Rate	The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.	At the end of 4 weeks
Plasma E-Selectin	E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).	At the end of 4 weeks
Plasma P-Selectin	P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).	At the end of 4 weeks
Total Sleep Time	The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.	At the end of 4 weeks
Nocturnal Dipping of Blood Pressure	Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.	At the end of 4 weeks
Percentage of Participants With Melatonin-related Side Effect.		After 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Frederic F Rahbari Oskoui, MD, MSCR, Emory University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: November 15, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension; Melatonin; Sleep; Endothelial function; Cardiovascular; African American; Blood Pressure; Sympathetic Nervous System; Catecholamines; Nocturnal; Nighttime
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: IRB00021300; 1R21AT004509-01A2 (U.S. NIH Grant/Contract)