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

NCT ID: NCT01114373

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-09-30

Brief 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.

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

Study Design

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

Study Groups

Melatonin

Subjects with mild to moderate essential hypertension will be given 24mg time release melatonin for 4 weeks either before or after exposure to 4 week of placebo with no washout period.

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.

Placebo

Subjects with mild to moderate essential hypertension will be given placebo for 4 weeks either before or after exposure to 4 weeks of 24mg daily dose of time release melatonin with no washout period.

Group Type: PLACEBO_COMPARATOR

Melatonin

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.

Interventions

Melatonin

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.

Intervention Type: DRUG

Placebo

Subjects will receive placebo pills (3 pills) 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) > 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.

• 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

3R21AT004509-01A2S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00021300a

Identifier Type: -

Identifier Source: org_study_id