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| ID | Type | Description | Link |
|---|---|---|---|
| 3R21AT004509-01A2S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic F Rahbari-Oskoui, MD, MSCR | Emory University | Principal Investigator |
| Arlene Chapman, M.D. | Emory University | Principal Investigator |
| Donald Bliwise, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
39 patients who came for screening visit, did not make it to the randomization phase either because they didn't meet eligibility criteria or they decided not to pursue with the study procedure.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Melatonin | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks. |
| FG001 | Melatonin/Placebo | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (4 Weeks) |
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| |||||||||||||||||||||
| Intervention 2 (4 Weeks) |
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36 subjects completed the entire study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
8 weeks
36 subjects completed the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederic Rahbari-Oskoui, Associate Professor of Medicine | Emory University | 404-727-3425 | frahbar@emory.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Subjects will receive placebo pills (3 pills) to be taken orally once per night for 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 4 weeks |
| Terminated by PI after protocol violatio |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | beats per minute | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | mmHg | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | beats per minute | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | ng/ml/min | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | ng/ml/min | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | ng/ml/min | 4 weeks |
|
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Error | ng/ml | 4 weeks |
|
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Error | ng/ml | 4 weeks |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | minutes | 4 weeks |
|
|
|
|
| 0 |
| 36 |
| 21 |
| 36 |
| EG001 | Placebo | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin). | 0 | 36 | 25 | 36 |
| Daytime drowsiness | General disorders | Systematic Assessment |
|
| Early Morning Wakening | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| 0.95 |
| 2-Sided |
| No |
| Superiority or Other |