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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT01114373
First received: April 29, 2010
Last updated: January 27, 2016
Last verified: January 2016
Results First Received: September 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Melatonin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

79 patients came for screening visit. 39 patients were either screen failures or did not want to pursue the study procedures prior to randomization.

Ultimately 40 patients were randomized. 4 patients dropped out and 36 completed both arms of the study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
39 patients who came for screening visit, did not make it to the randomization phase either because they didn't meet eligibility criteria or they decided not to pursue with the study procedure.

Reporting Groups
  Description
Placebo/Melatonin African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
Melatonin/Placebo African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.

Participant Flow for 2 periods

Period 1:   Intervention 1 (4 Weeks)
    Placebo/Melatonin     Melatonin/Placebo  
STARTED     21     19  
COMPLETED     18     19  
NOT COMPLETED     3     0  
Lost to Follow-up                 1                 0  
Incarceration                 1                 0  
Terminated by PI after protocol violatio                 1                 0  

Period 2:   Intervention 2 (4 Weeks)
    Placebo/Melatonin     Melatonin/Placebo  
STARTED     18     19  
COMPLETED     18     18  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
36 subjects completed the entire study.

Reporting Groups
  Description
All Subjects African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  48.9  (9.9)  
Gender  
[units: participants]
 
Female     25  
Male     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Nighttime Systolic Blood Pressure (SBP)   [ Time Frame: 4 weeks ]

2.  Primary:   Mean Nighttime Diastolic Blood Pressure (DBP)   [ Time Frame: 4 weeks ]

3.  Secondary:   Mean Nighttime Mean Arterial Pressure (MAP)   [ Time Frame: 4 weeks ]

4.  Secondary:   Mean Nighttime Heart Rate (HR)   [ Time Frame: 4 weeks ]

5.  Secondary:   Mean Daytime Systolic Blood Pressure (SBP)   [ Time Frame: 4 weeks ]

6.  Secondary:   Mean Daytime Diastolic Blood Pressure (DBP)   [ Time Frame: 4 weeks ]

7.  Secondary:   Mean Daytime Mean Arterial Pressure (MAP)   [ Time Frame: 4 weeks ]

8.  Secondary:   Mean Daytime Heart Rate (HR)   [ Time Frame: 4 weeks ]

9.  Secondary:   Urinary Dopamine Excretion Rate   [ Time Frame: 4 weeks ]

10.  Secondary:   Urinary Noradrenaline Excretion Rate   [ Time Frame: 4 weeks ]

11.  Secondary:   Urinary Adrenaline Excretion Rate   [ Time Frame: 4 weeks ]

12.  Secondary:   Plasma E-Selectin   [ Time Frame: 4 weeks ]

13.  Secondary:   Plasma P-Selectin   [ Time Frame: 4 weeks ]

14.  Secondary:   Total Sleep Time   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frederic Rahbari-Oskoui, Associate Professor of Medicine
Organization: Emory University
phone: 404-727-3425
e-mail: frahbar@emory.edu



Responsible Party: Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier: NCT01114373     History of Changes
Other Study ID Numbers: IRB00021300a
3R21AT004509-01A2S1 ( US NIH Grant/Contract Award Number )
Study First Received: April 29, 2010
Results First Received: September 15, 2015
Last Updated: January 27, 2016
Health Authority: United States: Food and Drug Administration