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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT01114373
First received: April 29, 2010
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: 24 mg time release melatonin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Nighttime systolic blood pressure (based on 24h ambulatory blood pressure monitoring) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daytime systolic blood pressure (based on 24h ambulatory blood pressure monitoring) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Sleep duration and quality [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Urinary catecholamines [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Markers of endothelial function [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Melatonin-related side effects [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 mg time-release melatonin
Once a night 24 mg time-release melatonin for 4 weeks.
Drug: 24 mg time release melatonin
3 x 8 mg time release melatonin pills, once per night for 4 weeks
Placebo Comparator: Placebo
24 mg of placebo once a night for 4 weeks
Drug: Placebo
3 x placebo pills, once per night for 4 weeks

Detailed Description:

The main outcome of interest is the mean nighttime blood pressure. We are also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies (to see if Melatonin lower blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.

We are also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.

Finally, we are looking into changes in vascular biology markers P-selectin and e-selectin) on Melatonin.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males of females ages 18 to 64
  • Prior history of elevated nighttime BP (SBP > 125)
  • 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 TIA)
  • Diabetes mellitus (Type 1 or 2)
  • Cancer/malignancy other than nonmelanoma skin cancer
  • Primary renal disease
  • Serum creatinine > 1.5 in men or > 1.4 in women
  • Severe anemia
  • Liver enzymes > 2.5 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, 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: Vitamin methyl B12, St. Johns Wort, feverfew, black and white mustard seeds, wolf berry seed
  • Sleep apnea
  • Night work
  • Women who are pregnant, breast feeding, attempting conception, or planning to attempt conception over the next 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114373

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Frederic F Rahbari-Oskoui, MD, MSCR Emory University
Principal Investigator: Arlene Chapman, M.D. Emory University
Principal Investigator: Donald Bliwise, Ph.D. Emory University
  More Information

No publications provided

Responsible Party: Frederic Rahbari-Oskoui, MD, MSCR, Assistant Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01114373     History of Changes
Other Study ID Numbers: IRB00021300a, 3R21AT004509-01A2S1
Study First Received: April 29, 2010
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Melatonin
Hypertension
Blood Pressure
Cardiovascular
Sleep
Nighttime
Nocturnal
Catecholamines
Sympathetic Nervous System
Endothelial Function
African American

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014