Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT004509-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 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. |
|
| 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 were reported. | 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 | At the end of 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 were reported | At the end of 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
After signing the ICF and going through screening procedures, 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.
80 patients were screened. 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.
37 patients were randomized. There was 1 dropout, and 36 patients completed both arms of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Melatonin | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks. |
| FG001 | Melatonin/Placebo | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (4 Weeks) |
|
| ||||||||||||||||||
| Intervention 2 (4 Weeks) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin 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 were reported. | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | mmHg | At the end of 4 weeks |
|
4 weeks on each arm.
Not provided
Not provided
| 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 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | ICD-9 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederic Rahbari-Oskoui, Associate Professor of Medicine | Emory University | 404-727-2590 | frahbar@emory.edu |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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). | 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). | 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. | 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. | At the end of 4 weeks |
| Percentage of Participants With Melatonin-related Side Effect. | After 4 weeks of treatment |
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin). |
|
|
|
| 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 were reported | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | mmHg | At the end of 4 weeks |
|
|
|
|
| Secondary | 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 | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | beats per minute | At the end of 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 were reported | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | mmHg | At the end of 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 were reported | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | mmHg | At the end of 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 were 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 | At the end of 4 weeks |
|
|
|
|
| Secondary | 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 | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | beats per minute | At the end of 4 weeks |
|
|
|
|
| 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 were reported | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | mmHg | At the end of 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. | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | ng/ml/min | At the end of 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. | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | ng/ml/min | At the end of 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 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls. | Posted | Mean | Standard Error | ng/ml/min | At the end of 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). | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | ng/ml | At the end of 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). | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | ng/ml | At the end of 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. | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Mean | Standard Error | minutes | At the end of 4 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | percentage ratio in night/day SBP | At the end of 4 weeks |
|
|
|
| Secondary | Percentage of Participants With Melatonin-related Side Effect. | 37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls. | Posted | Number | percentage of total number of patients | After 4 weeks of treatment |
|
|
|
| 0 |
| 36 |
| 17 |
| 36 |
| EG001 | Placebo | African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin). | 0 | 36 | 18 | 36 |
| Daytime drowsiness | General disorders | ICD-9 | Systematic Assessment |
|
| Early Morning Wakening | General disorders | ICD-9 | Systematic Assessment |
|
| Dizziness | General disorders | ICD-9 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ICD-9 | Systematic Assessment |
|
| Weakness | General disorders | ICD-9 | Systematic Assessment |
|
| Blurred vision | Eye disorders | ICD-9 | Systematic Assessment |
|
| Heart palpitations | Cardiac disorders | ICD-9 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |