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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

April 29, 2010
October 3, 2014
June 2010
July 2014   (final data collection date for primary outcome measure)
Nighttime systolic blood pressure (based on 24h ambulatory blood pressure monitoring) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Nighttime ambulatory blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114373 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study
Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: 24 mg time release melatonin
    3 x 8 mg time release melatonin pills, once per night for 4 weeks
  • Drug: Placebo
    3 x placebo pills, once per night for 4 weeks
  • Active Comparator: 24 mg time-release melatonin
    Once a night 24 mg time-release melatonin for 4 weeks.
    Intervention: Drug: 24 mg time release melatonin
  • Placebo Comparator: Placebo
    24 mg of placebo once a night for 4 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114373
IRB00021300a, 3R21AT004509-01A2S1
Yes
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
Emory University
National Center for Complementary and Alternative Medicine (NCCAM)
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
Emory University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP