Official Title: “Melatonin Supplementation in Hypertensive Patients”

This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. Beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in lowering blood pressure.

Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. Participants will take part in two inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks.

While in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. Blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. Throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.

Intervention(s) in this Clinical Trial

• Drug: Melatonin
  • 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Melatonin
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Change in sleep quality
  • Time Frame: measured during each inpatient phase
    Safety Issue?: No

Secondary Measures

• Change in blood pressure
  • Time Frame: measured before, during, and after each inpatient phase
    Safety Issue?: No

Inclusion Criteria:

• Diagnosed with uncomplicated hypertension
• Currently being treated with Atenolol (a beta-blocker)

Exclusion Criteria:

• History of medical illness other than essential hypertension
• Personal or family history of psychiatric illness
• Current use of any medication other than anti-hypertensive drugs
• Any recent travel across time zones
• History of working various shifts on an irregular basis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Overall Clinical Trial Officials and Contacts

Frank AJ Scheer, PhD Principal Investigator Brigham and Women's Hospital, Harvard Medical School  

Overall Contact: Erin Kelly, M.S. (617) 732-5737 ekelly19@rics.bwh.harvard.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238108

Study ID Number: R21 AT002713

ClinicalTrials.gov Identifier: NCT00238108

Health Authority: United States: Food and Drug Administration