HypertensionPhase 2NCT01114373

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

A Phase 2 study testing Melatonin in people with Hypertension, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Melatonin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Sep 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

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.

Conditions: Hypertension
Being tested: Melatonin, Placebo
Keywords: Melatonin, Hypertension, Blood Pressure, Cardiovascular, Sleep, Nighttime, Nocturnal, Catecholamines, Sympathetic Nervous System, Endothelial Function, African American
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01114373
Study group	Role	What they receive
Melatonin	Active comparator	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. Receives: Drug: Melatonin; Drug: Placebo
Placebo	Placebo comparator	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. Receives: Drug: Melatonin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 4 weeks

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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 are reported.
Measured: 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 are reported.
Measured: 4 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Sep 2014

First posted3 May 2010 (estimated)
Study startJun 2010
Primary completionSep 2013
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114373
Sponsor's protocol ID: IRB00021300a
Other IDs: 3R21AT004509-01A2S1
Status last verified: Jan 2016
First submitted: 29 Apr 2010
Last updated: 26 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study
ClinicalTrials.gov ID: NCT01114373
Acronym / sponsor ID: IRB00021300a
Conditions: Hypertension
Keywords: Melatonin, Hypertension, Blood Pressure, Cardiovascular, Sleep, Nighttime, Nocturnal, Catecholamines
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jun 2010
Primary completion: Sep 2013 (actual)
Study completion: Sep 2014 (actual)
First posted: 3 May 2010 (estimated)
Results: Posted 18 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Melatonin	Active comparator	Drug: Melatonin, Drug: PlaceboSubjects 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.
Placebo	Placebo comparator	Drug: Melatonin, Drug: PlaceboSubjects 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MelatoninMelatonin (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.	Drug	Melatonin, Placebo
PlaceboSubjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.	Drug	Melatonin, Placebo

Primary outcome

Mean Nighttime Systolic Blood Pressure (SBP)
Time frame: 4 weeks
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.
Mean Nighttime Diastolic Blood Pressure (DBP)
Time frame: 4 weeks
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.

12 secondary outcomes

Mean Nighttime Mean Arterial Pressure (MAP)
Time frame: 4 weeks
Mean Nighttime Heart Rate (HR)
Time frame: 4 weeks
Mean Daytime Systolic Blood Pressure (SBP)
Time frame: 4 weeks
Mean Daytime Diastolic Blood Pressure (DBP)
Time frame: 4 weeks
Mean Daytime Mean Arterial Pressure (MAP)
Time frame: 4 weeks
Mean Daytime Heart Rate (HR)
Time frame: 4 weeks
Urinary Dopamine Excretion Rate
Time frame: 4 weeks
Urinary Noradrenaline Excretion Rate
Time frame: 4 weeks
Urinary Adrenaline Excretion Rate
Time frame: 4 weeks
Plasma E-Selectin
Time frame: 4 weeks
Plasma P-Selectin
Time frame: 4 weeks
Total Sleep Time
Time frame: 4 weeks

Results and safety

Results posted to the registry on 18 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Melatonin	21	18
Melatonin/Placebo	19	19

Primary outcome: Mean Nighttime Systolic Blood Pressure (SBP)

Time frame: 4 weeks. Mean (Standard Error). Unit: mmHg

Measure	Melatonin n = 36	Placebo n = 36
Value	126.6 (2.3)	127.9 (2.3)

Melatonin vs Placebo: p = 0.0269, ANOVA
Melatonin vs Placebo: p = 0.84, ANOVA

Population analysed: 40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.

Primary outcome: Mean Nighttime Diastolic Blood Pressure (DBP)

Time frame: 4 weeks. Mean (Standard Error). Unit: mmHg

Measure	Melatonin n = 36	Placebo n = 36
Value	77.2 (1.7)	77.6 (1.7)

Melatonin vs Placebo: p = 0.0492, ANOVA
Melatonin vs Placebo: p = 0.95, ANOVA

Population analysed: 40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Melatonin	0 of 36 (0%)	21 of 36 (58.3%)	Not reported
Placebo	0 of 36 (0%)	25 of 36 (69.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melatonin in people with Hypertension, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Nighttime Systolic Blood Pressure (SBP) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01114373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.