Clinical trial NCT01114360: Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
Official title: Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Melatonin
Hypertension
Blood Pressure
Cardiovascular
Sleep
Nighttime
Nocturnal
Catecholamines
Sympathetic Nervous System
Endothelial function
African American
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-05-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Nighttime Systolic Blood Pressure (SBP)
timeFrame: At the end of 4 weeks
measure: Mean Nighttime Diastolic Blood Pressure (DBP)
timeFrame: At the end of 4 weeks
Secondary outcomes:
measure: Mean Nighttime Mean Arterial Pressure (MAP)
timeFrame: At the end of 4 weeks
measure: Mean Nighttime Heart Rate (HR)
timeFrame: At the end of 4 weeks
measure: Mean Daytime Systolic Blood Pressure (SBP)
timeFrame: At the end of 4 weeks
measure: Mean Daytime Diastolic Blood Pressure (DBP)
timeFrame: At the end of 4 weeks
measure: Mean Daytime Mean Arterial Pressure (MAP)
timeFrame: At the end of 4 weeks
measure: Mean Daytime Heart Rate (HR)
timeFrame: At the end of 4 weeks
measure: Urinary Dopamine Excretion Rate
timeFrame: At the end of 4 weeks
measure: Urinary Noradrenaline Excretion Rate
timeFrame: At the end of 4 weeks
measure: Urinary Adrenaline Excretion Rate
timeFrame: At the end of 4 weeks
measure: Plasma E-Selectin
timeFrame: At the end of 4 weeks
measure: Plasma P-Selectin
timeFrame: At the end of 4 weeks
measure: Total Sleep Time
timeFrame: At the end of 4 weeks
measure: Nocturnal Dipping of Blood Pressure
timeFrame: At the end of 4 weeks
measure: Percentage of Participants With Melatonin-related Side Effect.
timeFrame: After 4 weeks of treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Frederic F Rahbari Oskoui, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Arlene Chapman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Donald Bliwise, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: