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

Tracking Information

First Received Date ^ICMJE

April 29, 2010

Last Updated Date

March 6, 2013

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01114373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 24 mg time-release melatonin
Intervention: Drug: 24 mg time release melatonin
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Adam Bruckman, MPH

404-727-6521

adambruckman@emory.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01114373

Other Study ID Numbers ^ICMJE

3R21AT004509-01A2S1

Has Data Monitoring Committee

Yes

Responsible Party

Frederic Rahbari-Oskoui, MD, MSCR, Emory University

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

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

Information Provided By

Emory University

Verification Date

March 2013

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

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