Trial of Oral Melatonin in Elevated Blood Pressure (MRCTEBP)

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Elevated Blood Pressure

Treatments: Drug: Melatonin/experimental; Drug: Placebo oral capsule/placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT03764020

TUMS

Details and patient eligibility

About

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

Full 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

Enrollment: 320 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Intervention group1: Melatonin,capsule,3 mg, one dose one hour before bedtime, three weeks

Treatment:

Drug: Melatonin/experimental

Placebo

Placebo Comparator group

Description:

Intervention group2 : Placebo, capsule, 3 mg, one dose one hour before bedtime, for three weeks

Treatment:

Drug: Placebo oral capsule/placebo comparator