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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

April 29, 2010
November 15, 2015
March 2010
September 2013   (final data collection date for primary outcome measure)
  • 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
Nighttime ambulatory blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114360 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Daytime ambulatory blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Sleep duration and quality [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Urinary catecholamines [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Markers of endothelial function [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Melatonin-related side effects [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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.
  • 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).
    Interventions:
    • Drug: Melatonin
    • Drug: Placebo
  • 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)
    Interventions:
    • Drug: Melatonin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114360
IRB00021300, 1R21AT004509-01A2
Yes
Not Provided
Not Provided
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
Emory University
National Center for Complementary and Integrative Health (NCCIH)
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
Emory University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP