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Completed

NCT Number: NCT01114360

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

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.

Placebo

Drug

Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Mean Nighttime Mean Arterial Pressure (MAP)

    Time frame: At the end of 4 weeks

    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

  2. Mean Nighttime Heart Rate (HR)

    Time frame: At the end of 4 weeks

    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

  3. Mean Daytime Systolic Blood Pressure (SBP)

    Time frame: At the end of 4 weeks

    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

  4. Mean Daytime Diastolic Blood Pressure (DBP)

    Time frame: At the end of 4 weeks

    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

  5. Mean Daytime Mean Arterial Pressure (MAP)

    Time frame: At the end of 4 weeks

    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.

  6. Mean Daytime Heart Rate (HR)

    Time frame: At the end of 4 weeks

    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

  7. Urinary Dopamine Excretion Rate

    Time frame: At the end of 4 weeks

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

  8. Urinary Noradrenaline Excretion Rate

    Time frame: At the end of 4 weeks

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

  9. Urinary Adrenaline Excretion Rate

    Time frame: At the end of 4 weeks

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

  10. Plasma E-Selectin

    Time frame: At the end of 4 weeks

    E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).

  11. Plasma P-Selectin

    Time frame: At the end of 4 weeks

    P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).

  12. Total Sleep Time

    Time frame: At the end of 4 weeks

    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.

  13. Nocturnal Dipping of Blood Pressure

    Time frame: At the end of 4 weeks

    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.

  14. Percentage of Participants With Melatonin-related Side Effect.

    Time frame: After 4 weeks of treatment

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 3, 2010
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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