Skip to main content
Clinical Trials/NCT00238108
NCT00238108CompletedPhase 2

Melatonin Supplementation in Hypertensive Patients

Brigham and Women's Hospital1 site in 1 country16 target enrollmentStarted: October 2005Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Sleep Quality

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
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

Arms & Interventions

1

Experimental

Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks)

Intervention: Melatonin (Drug)

2

Placebo Comparator

Placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Sleep Quality

Time Frame: Measurement after 3 weeks of supplementation

Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)

Secondary Outcomes

  • Change in Systolic Blood Pressure(Measurement after 3 weeks of supplementation compared to baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Frank AJL Scheer, PhD

Assistant Professor of Medicine

Brigham and Women's Hospital

Study Sites (1)

Loading locations...

Similar Trials