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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT01114360
First received: April 29, 2010
Last updated: November 15, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Hypertension
Drug: Melatonin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Mean Nighttime Systolic Blood Pressure (SBP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Nighttime Diastolic Blood Pressure (DBP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mean Nighttime Mean Arterial Pressure (MAP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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

  • Mean Nighttime Heart Rate (HR) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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

  • Mean Daytime Systolic Blood Pressure (SBP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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

  • Mean Daytime Diastolic Blood Pressure (DBP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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

  • Mean Daytime Mean Arterial Pressure (MAP) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Daytime Heart Rate (HR) [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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

  • Urinary Dopamine Excretion Rate [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

  • Urinary Noradrenaline Excretion Rate [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

  • Urinary Adrenaline Excretion Rate [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

  • Plasma E-Selectin [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).

  • Plasma P-Selectin [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).

  • Total Sleep Time [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Nocturnal Dipping of Blood Pressure [ Time Frame: At the end of 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Melatonin-related Side Effect. [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: March 2010
Study Completion Date: September 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114360

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Frederic F Rahbari Oskoui, MD, MSCR Emory University
Principal Investigator: Arlene Chapman, M.D. Emory University
Principal Investigator: Donald Bliwise, Ph.D. Emory University
  More Information

Responsible Party: Frederic Rahbari-Oskoui, MD, MSCR, Associate Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01114360     History of Changes
Other Study ID Numbers: IRB00021300  1R21AT004509-01A2 
Study First Received: April 29, 2010
Results First Received: September 15, 2015
Last Updated: November 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Melatonin
Hypertension
Blood Pressure
Cardiovascular
Sleep
Nighttime
Nocturnal
Catecholamines
Sympathetic Nervous System
Endothelial function
African American

Additional relevant MeSH terms:
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016