Melatonin and Nighttime Blood Pressure in African Americans-8 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:
NCT01114360
First received: April 29, 2010
Last updated: November 15, 2015
Last verified: November 2015
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

80 patients were screened. 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.

37 patients were randomized. There was 1 dropout, and 36 patients 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
After signing the ICF and going through screening procedures, 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.

Reporting Groups
  Description
Placebo/Melatonin African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
Melatonin/Placebo African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.

Participant Flow for 2 periods

Period 1:   Intervention 1 (4 Weeks)
    Placebo/Melatonin     Melatonin/Placebo  
STARTED     18     19  
COMPLETED     18     18  
NOT COMPLETED     0     1  
Physician Decision                 0                 1  

Period 2:   Intervention 2 (4 Weeks)
    Placebo/Melatonin     Melatonin/Placebo  
STARTED     18     18  
COMPLETED     18     18  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
All Participants African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Gender  
[units: participants]
 
Female     25  
Male     11  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

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

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

9.  Secondary:   Urinary Dopamine Excretion Rate   [ Time Frame: At the end of 4 weeks ]

10.  Secondary:   Urinary Noradrenaline Excretion Rate   [ Time Frame: At the end of 4 weeks ]

11.  Secondary:   Urinary Adrenaline Excretion Rate   [ Time Frame: At the end of 4 weeks ]

12.  Secondary:   Plasma E-Selectin   [ Time Frame: At the end of 4 weeks ]

13.  Secondary:   Plasma P-Selectin   [ Time Frame: At the end of 4 weeks ]

14.  Secondary:   Total Sleep Time   [ Time Frame: At the end of 4 weeks ]

15.  Secondary:   Nocturnal Dipping of Blood Pressure   [ Time Frame: At the end of 4 weeks ]

16.  Secondary:   Percentage of Participants With Melatonin-related Side Effect.   [ Time Frame: After 4 weeks of treatment ]


  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: 404-727-2590
e-mail: frahbar@emory.edu



Responsible Party: Frederic Rahbari-Oskoui, MD, MSCR, Emory University
ClinicalTrials.gov Identifier: NCT01114360     History of Changes
Other Study ID Numbers: IRB00021300
1R21AT004509-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: April 29, 2010
Results First Received: September 15, 2015
Last Updated: November 15, 2015
Health Authority: United States: Food and Drug Administration