Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Melatonin; Placebo
Intervention description: 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.; Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Melatonin; Hypertension; Blood Pressure; Cardiovascular; Sleep; Nighttime; Nocturnal; Catecholamines; Sympathetic Nervous System; Endothelial Function; African American

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ages 18 to 64

          -  Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure
             (SBP) > 115mmHg))

          -  Taking no more than 2 antihypertensive medications

          -  African American (self-defined by the participant)

        Exclusion Criteria:

          -  Secondary forms of hypertension

          -  Presence of other diseases requiring treatment with BP lowering medication

          -  Known cardiovascular disease (including history of angina pectoris, heart failure,
             presence of a cardiac pacemaker, history of myocardial infarction or revascularization
             procedure, or history of 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 > 1.4 mg/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 inhibitors (COX2-I), 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: 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.