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

NCT01114373 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB00021300a3R21AT004509-01A2S1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean Nighttime Systolic Blood Pressure (SBP)

  The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.

  4 weeks

• Mean Nighttime Diastolic Blood Pressure (DBP)

  The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.

  4 weeks

Secondary Outcomes (12)

• Mean Nighttime Mean Arterial Pressure (MAP)

  4 weeks

• Mean Nighttime Heart Rate (HR)

  4 weeks

• Mean Daytime Systolic Blood Pressure (SBP)

  4 weeks

• Mean Daytime Diastolic Blood Pressure (DBP)

  4 weeks

• Mean Daytime Mean Arterial Pressure (MAP)

  4 weeks

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

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.

Drug: Melatonin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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.

Drug: Melatonin; Drug: Placebo

Interventions

Melatonin 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.

Melatonin; Placebo

Placebo DRUG

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

Melatonin; Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Emory University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Frederic Rahbari-Oskoui, Associate Professor of Medicine
• Organization: Emory University

frahbar@emory.edu

404-727-3425

Study Officials

• Frederic F Rahbari-Oskoui, MD, MSCR

  Emory University

  PRINCIPAL INVESTIGATOR

• Arlene Chapman, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

• Donald Bliwise, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 26, 2016
• Results First Posted: December 18, 2015

Record last verified: 2016-01

Locations

US (1)