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

NCT ID: NCT01114360

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Hypertension

Keywords

Melatonin; Hypertension; Blood Pressure; Cardiovascular; Sleep; Nighttime; Nocturnal; Catecholamines; Sympathetic Nervous System; Endothelial function; African American

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Melatonin

African-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure).

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: 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

Intervention Type: DRUG

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

Placebo

African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)

Group Type: PLACEBO_COMPARATOR

Melatonin

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Melatonin

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Frederic Rahbari-Oskoui, MD, MSCR

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederic F Rahbari Oskoui, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Emory University

Arlene Chapman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Donald Bliwise, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1R21AT004509-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00021300

Identifier Type: -

Identifier Source: org_study_id