HypertensionPhase 2NCT01114360
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
A Phase 2 study testing Melatonin in people with Hypertension, run by Emory University at 1 site in United States.
Trial summary
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. 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
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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) >115 mmHg))
- Taking no more than 2 antihypertensive medications
- African-American race (self-defined by the participant)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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 8 mg time-release melatonin pills, orally, once per night for 4 weeks.
PlaceboDrug
Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | 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). Receives: Drug: Melatonin; Drug: Placebo |
| Placebo | Placebo comparator | African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin) 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 were reported.
Measured: 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
Measured: At the end of 4 weeks
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At the end of 4 weeks
Percentage of Participants With Melatonin-related Side Effect.
Measured: After 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMar 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Frederic Rahbari-Oskoui, MD, MSCR, Emory University
- Investigators
- Frederic F Rahbari Oskoui, MD, MSCR, Principal investigator, Emory UniversityArlene Chapman, M.D., Principal investigator, Emory UniversityDonald Bliwise, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114360
- Sponsor's protocol ID
- IRB00021300
- Other IDs
- 1R21AT004509-01A2
- Status last verified
- Nov 2015
- First submitted
- 29 Apr 2010
- Last updated
- 18 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study
- ClinicalTrials.gov ID
- NCT01114360
- Acronym / sponsor ID
- IRB00021300
- Conditions
- Hypertension
- Keywords
- Melatonin, Hypertension, Blood Pressure, Cardiovascular, Sleep, Nighttime, Nocturnal, Catecholamines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 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.
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.
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 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: PlaceboAfrican-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure). |
| Placebo | Placebo comparator | Drug: Melatonin, Drug: PlaceboAfrican-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin) |
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) >115 mmHg))
- Taking no more than 2 antihypertensive medications
- African-American race (self-defined by the participant)
Key exclusion criteria (16 listed)
- 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
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 8 mg time-release melatonin pills, orally, once per night for 4 weeks. | Drug | Melatonin, Placebo |
| PlaceboSubjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks. | Drug | Melatonin, Placebo |
Primary outcome
Mean Nighttime Systolic Blood Pressure (SBP)
Time frame: At the end of 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 were reported.
Mean Nighttime Diastolic Blood Pressure (DBP)
Time frame: At the end of 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 were reported
14 secondary outcomes
Mean Nighttime Mean Arterial Pressure (MAP)
Time frame: At the end of 4 weeks
Mean Nighttime Heart Rate (HR)
Time frame: At the end of 4 weeks
Mean Daytime Systolic Blood Pressure (SBP)
Time frame: At the end of 4 weeks
Mean Daytime Diastolic Blood Pressure (DBP)
Time frame: At the end of 4 weeks
Mean Daytime Mean Arterial Pressure (MAP)
Time frame: At the end of 4 weeks
Mean Daytime Heart Rate (HR)
Time frame: At the end of 4 weeks
Urinary Dopamine Excretion Rate
Time frame: At the end of 4 weeks
Urinary Noradrenaline Excretion Rate
Time frame: At the end of 4 weeks
Urinary Adrenaline Excretion Rate
Time frame: At the end of 4 weeks
Plasma E-Selectin
Time frame: At the end of 4 weeks
Plasma P-Selectin
Time frame: At the end of 4 weeks
Total Sleep Time
Time frame: At the end of 4 weeks
Nocturnal Dipping of Blood Pressure
Time frame: At the end of 4 weeks
Percentage of Participants With Melatonin-related Side Effect.
Time frame: After 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 18 Dec 2015. 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: At the end of 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?
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 18 Dec 2015.