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

This study is currently recruiting participants.
Verified March 2013 by Emory University
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT01114373
First received: April 29, 2010
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Nighttime ambulatory blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daytime ambulatory blood pressure [ 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: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 mg time-release melatonin Drug: 24 mg time release melatonin
3 x 8 mg time release melatonin pills, once per night for 4 weeks
Placebo Comparator: Placebo Drug: Placebo
3 x placebo pills, once per night for 4 weeks

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

Contacts
Contact: Adam Bruckman, MPH 404-727-6521 adambruckman@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Center for Complementary and Alternative Medicine (NCCAM)
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: 3R21AT004509-01A2S1
Study First Received: April 29, 2010
Last Updated: March 6, 2013
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
Vascular Diseases
Cardiovascular Diseases
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013