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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Melatonin

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.