Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01114373

Run by

Emory University

People needed

40

Starts

2010-06-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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