Trial of Oral Melatonin in Elevated Blood Pressure (MRCTEBP)

April 9, 2019 updated by: Zinat Hatmi, Tehran University of Medical Sciences

A Triple Blinded Randomized Controlled Trial of Oral Melatonin in Elevated Blood Pressure Individual (MRCTEBP)

Since, lowering blood pressure (BP) in elevated blood pressure individuals represents an excellent opportunity to for primary prevention of hypertension (HTN). Therefore, it is planned to use a safe treatment option - oral melatonin supplementation - associated with lifestyle interventions according to the American college of cardiology/American heart association (ACC/AHA) 2013 guideline in elevated blood pressure individuals to mitigate systolic and diastolic BP and ultimately, to prevent the development of HTN.

Hypothesis:

Melatonin therapy can lower the systolic and diastolic BP of elevated blood pressure individuals Melatonin can attenuate levels of circulatory biomarkers of Hs- CRP, Cholesterol, LDL-c and triglyceride

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study design: Randomized controlled trial (RCT)

Study population: Elevated blood pressure individuals who present themselves at the outpatient clinics of Tehran Heart Centre(THC) , seeking blood pressure treatment and who have a systolic blood pressure of 120-129 mmHg or a diastolic blood pressure of =80 mmHg.

Treatment groups: Melatonin 3 mg versus placebo

sample size: 160 per group ( 320 overall)

Treatment allocation: After completing informed consent and prior to randomization, all participants undergo complete physical examination and laboratory test. Baseline levels of inflammatory biomarkers and pregnancy test (for women in reproductive age) will be performed. Sleep quality, actual sleep time, and sleep latency will be recorded.

Treatment plan: Three weeks melatonin 3 Mg or placebo one hour before bedtime has been planned. All of the melatonin and placebo capsules will be supplied from a single hospital pharmacy and free of charge to the participants. Melatonin and placebo capsules will be identical. Participants will receive a three weeks supply at the assignment time. Besides, all participants will receive a careful plan of adherence to a heart-healthy diet, regular exercise, instruction for avoidance of tobacco use and maintenance of a healthy body mass index (BMI) according to 2013ACC/ AHA guideline.

Follow up: Three weeks

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with systolic blood pressure120-129 and/or diastolic blood pressure =80mmHg
  • Negative pregnancy test for women at productive age
  • Baseline melatonin and biomarkers level and complete liver function tests within normal range

Exclusion Criteria:

  • Previous history of hypersensitivity of melatonin
  • Past history of using antihypertensive treatment
  • Past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy and other physician documented diseases
  • Use of beta-blockers, sleep aids, warfarin, flaxseed, soy and supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin

Intervention group1:

Melatonin,capsule,3 mg, one dose one hour before bedtime, three weeks
Drug: Melatonin/experimental
Melatonin ,capsule, 3 mg, one dose one hour before bedtime, for three weeks along with life style modification according to ACC/AHA 2013 guideline.
Other Names:
  • Melatona
Placebo Comparator: Placebo

Intervention group2 :

Placebo, capsule, 3 mg, one dose one hour before bedtime, for three weeks
Drug: Placebo oral capsule/placebo comparator
3 mg placebo capsule one hour before bedtime for three weeks along with life style modification according to ACC/AHA 2013 guideline
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in systolic blood pressure from baseline
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in systolic blood pressure. The best outcome value is < and =120 millimeter mercury. Systolic blood pressure ranges between 90-250 millimeter mercury.
From enrollment to end of treatment at 3 weeks
Mean change in diastolic blood pressure from baseline
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in systolic blood pressure. The best outcome value is < 80 millimeter mercury. Diastolic blood pressure ranges between 60-140 millimeter mercury.
From enrollment to end of treatment at 3 weeks
Mean change in cholesterol
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in cholesterol in Milligram/deciliter from baseline, it measures average changes in cholesterol. The best outcome value is 200 milligram per deciliter. Total cholesterol less than 200 milligram per deciliter are considered desirable for adults. A reading between200-239 is considered borderline and a reading of 240 above is considered high.
From enrollment to end of treatment at 3 weeks
Mean change in low density lipoprotein
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in low density lipoprotein in Milligram/deciliter from baseline, it measures average changes in low density lipoprotein. The best outcome value is 100 milligram per deciliter. LDL level less than 100 milligram per deciliter is considered desirable, 100-130 borderline, 130-189 borderline high and above 190 is considered high.
From enrollment to end of treatment at 3 weeks
Mean change in fasting blood sugar
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in fasting blood sugar in Milligram/deciliter from baseline, it measures average changes in fasting blood sugar. Fasting blood sugar 72-99 milligram per deciliter is considered normal, 100-116 borderline and above 116 is considered high.
From enrollment to end of treatment at 3 weeks
Mean change in inflammatory biomarker
Time Frame: From enrollment to end of treatment at 3 weeks

Mean change in high sensitive C reactive protein (Hs-CRP) in Milligram/liter, it measures average changes in high sensitive C reactive protein (Hs-CRP). The best outcome value is <= 3 milligram per liter.

1-3 milligram per liter is considered normal and above 3 is considered high.
From enrollment to end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in sleep quality score from baseline
Time Frame: From enrollment to end of treatment at 3 weeks
Mean change in Pittsburg sleep quality questionnaire in Likert numerical score from baseline, it measures average changes in sleep quality score. Pittsburg sleep quality questionnaire score of 5 or greater is indicative of poor sleep quality.
From enrollment to end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: zinat Hatmi, Dr, Tehran University Of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

December 2, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tums

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

In case of designing systematic reviews and according to Helsinki declaration might be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Elevated Blood Pressure

Clinical Trials on Melatonin/experimental

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe