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CompletedNCT01114373Updated Feb 26, 2016Results posted

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

A Phase 2 interventional study of Melatonin and Placebo in Hypertension, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Emory University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Melatonin
  • Hypertension
  • Blood Pressure
  • Cardiovascular
  • Sleep
  • Nighttime
  • Nocturnal
  • Catecholamines
  • Sympathetic Nervous System
  • Endothelial Function
  • African American
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Melatonin

    Subjects with mild to moderate essential hypertension will be given 24mg time release melatonin for 4 weeks either before or after exposure to 4 week of placebo with no washout period.

    Drug: Melatonin · Drug: Placebo

  • Placebo comparator
    Placebo

    Subjects with mild to moderate essential hypertension will be given placebo for 4 weeks either before or after exposure to 4 weeks of 24mg daily dose of time release melatonin with no washout period.

    Drug: Melatonin · Drug: Placebo

Interventions

  • DrugMelatonin

    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.

  • DrugPlacebo

    Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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 are reported.

    Time frame: 4 weeks

  5. 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 are reported.

    Time frame: 4 weeks

  6. Mean Daytime Heart Rate (HR)

    Daytime 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

  7. 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.

    Time frame: 4 weeks

  8. 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.

    Time frame: 4 weeks

  9. 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.

    Time frame: 4 weeks

  10. 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).

    Time frame: 4 weeks

  11. 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).

    Time frame: 4 weeks

  12. 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.

    Time frame: 4 weeks

07

Results

Posted Dec 18, 2015

Participant flow

79 patients came for screening visit. 39 patients were either screen failures or did not want to pursue the study procedures prior to randomization. Ultimately 40 patients were randomized. 4 patients dropped out and 36 completed both arms of the study.

Intervention 1 (4 Weeks)
Participant flow — Intervention 1 (4 Weeks)
MilestonePlacebo/MelatoninMelatonin/Placebo
Started2119
Completed1819
Not completed30
Withdrew: Lost to follow-up10
Withdrew: Incarceration10
Withdrew: Terminated by pi after protocol violatio10
Intervention 2 (4 Weeks)
Participant flow — Intervention 2 (4 Weeks)
MilestonePlacebo/MelatoninMelatonin/Placebo
Started1819
Completed1818
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryMean 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
Reported as:
Mean · mmHg
Mean Nighttime Systolic Blood Pressure (SBP)
mmHgMelatoninPlacebo
Mean Nighttime Systolic Blood Pressure (SBP)126.6 ± 2.3127.9 ± 2.3
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.0269
  • Melatonin vs Placebo · ANOVA · p = 0.84
PrimaryMean 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
Reported as:
Mean · mmHg
Mean Nighttime Diastolic Blood Pressure (DBP)
mmHgMelatoninPlacebo
Mean Nighttime Diastolic Blood Pressure (DBP)77.2 ± 1.777.6 ± 1.7
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.0492
  • Melatonin vs Placebo · ANOVA · p = 0.95
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Nighttime Mean Arterial Pressure (MAP)
mmHgMelatoninPlacebo
Mean Nighttime Mean Arterial Pressure (MAP)93.9 ± 1.894.4 ± 1.8
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.91
SecondaryMean 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
Reported as:
Mean · beats per minute
Mean Nighttime Heart Rate (HR)
beats per minuteMelatoninPlacebo
Mean Nighttime Heart Rate (HR)74.1 ± 1.974.4 ± 1.9
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.88
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Daytime Systolic Blood Pressure (SBP)
mmHgMelatoninPlacebo
Mean Daytime Systolic Blood Pressure (SBP)134.2 ± 2.4137.3 ± 2.4
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.16
SecondaryMean 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 are reported.

Time frame:
4 weeks
Reported as:
Mean · mmHg
Mean Daytime Diastolic Blood Pressure (DBP)
mmHgMelatoninPlacebo
Mean Daytime Diastolic Blood Pressure (DBP)85.3 ± 1.886.6 ± 1.8
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.12
SecondaryMean 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 are reported.

Time frame:
4 weeks
Reported as:
Mean · mmHg
Mean Daytime Mean Arterial Pressure (MAP)
mmHgMelatoninPlacebo
Mean Daytime Mean Arterial Pressure (MAP)101.26 ± 1.9103.5 ± 1.9
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.12
SecondaryMean Daytime Heart Rate (HR)

Daytime 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
Reported as:
Mean · beats per minute
Mean Daytime Heart Rate (HR)
beats per minuteMelatoninPlacebo
Mean Daytime Heart Rate (HR)81.6 ± 1.883.3 ± 1.8
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.21
SecondaryUrinary Dopamine Excretion Rate

The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

Time frame:
4 weeks
Reported as:
Mean · ng/ml/min
Urinary Dopamine Excretion Rate
ng/ml/minMelatoninPlacebo
Urinary Dopamine Excretion Rate115.5 ± 22.3130.8 ± 22
Statistical analysis
  • Melatonin vs Placebo · Friedman · p = 0.06
SecondaryUrinary Noradrenaline Excretion Rate

The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

Time frame:
4 weeks
Reported as:
Mean · ng/ml/min
Urinary Noradrenaline Excretion Rate
ng/ml/minMelatoninPlacebo
Urinary Noradrenaline Excretion Rate11.5 ± 2.717 ± 2.7
Statistical analysis
  • Melatonin vs Placebo · Friedman · p = 0.21
SecondaryUrinary Adrenaline Excretion Rate

The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.

Time frame:
4 weeks
Reported as:
Mean · ng/ml/min
Urinary Adrenaline Excretion Rate
ng/ml/minMelatoninPlacebo
Urinary Adrenaline Excretion Rate1.23 ± 0.171.76 ± 0.17
Statistical analysis
  • Melatonin vs Placebo · Friedman · p = 0.41
SecondaryPlasma 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).

Time frame:
4 weeks
Reported as:
Mean · ng/ml
Plasma E-Selectin
ng/mlMelatoninPlacebo
Plasma E-Selectin39.5 ± 2.241.0 ± 2.2
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.13
SecondaryPlasma 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).

Time frame:
4 weeks
Reported as:
Mean · ng/ml
Plasma P-Selectin
ng/mlMelatoninPlacebo
Plasma P-Selectin92.2 ± 9.798.6 ± 9.5
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.58
SecondaryTotal 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.

Time frame:
4 weeks
Reported as:
Mean · minutes
Total Sleep Time
minutesMelatoninPlacebo
Total Sleep Time415.8 ± 10.9413.4 ± 10.6
Statistical analysis
  • Melatonin vs Placebo · ANOVA · p = 0.39

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Melatonin—0/36 (0%)21/36 (58.3%)
Placebo—0/36 (0%)25/36 (69.4%)
Most frequent other events
Most frequent other events
EventMelatoninPlacebo
FatigueGeneral disorders15/3612/36
Early Morning WakeningGeneral disorders14/3610/36
Daytime drowsinessGeneral disorders13/3611/36
DizzinessGeneral disorders4/363/36
NauseaGastrointestinal disorders4/363/36
WeaknessGeneral disorders4/363/36
Blurred visionEye disorders4/364/36

Baseline characteristics

36 subjects completed the entire study.

Age, Categorical
Age, Categorical(Participants)All Subjects
<=18 years0
Between 18 and 65 years36
>=65 years0
Age, Continuous
Age, Continuous(years)All Subjects
Mean48.9 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female25
Male11
08

Study locations

1 site
  • Emory University
    Atlanta, Georgia 30322, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01114373
Lead sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Frederic Rahbari-Oskoui, MD, MSCR (Associate Professor of Medicine, Emory University) — Principal investigator
First posted
May 3, 2010
Start date
Jun 2010
Primary completion
Sep 2013
Completion
Sep 2014
Results posted
Dec 18, 2015
Last update
Feb 26, 2016

Study contacts

Frederic F Rahbari-Oskoui, MD, MSCR
principal investigator · Emory University
Arlene Chapman, M.D.
principal investigator · Emory University
Donald Bliwise, Ph.D.
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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