Trial of Oral Melatonin in Elevated Blood Pressure

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: Melatonin

Criteria

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