Trial of Oral Melatonin in Elevated Blood Pressure

Phase 3

• Conditions: Elevated Blood Pressure
• Interventions: Drug: Melatonin/experimental; Drug: Placebo oral capsule/placebo comparator

• Registration Number: NCT03764020
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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

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 Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-12-02
• Study First Posted: 2018-12-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10
• Study Start: 2019-06-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin/experimental	Intervention group1: Melatonin,capsule,3 mg, one dose one hour before bedtime, three weeks
Placebo	Placebo oral capsule/placebo comparator	Intervention group2 : Placebo, capsule, 3 mg, one dose one hour before bedtime, for three weeks

Primary Outcome Measures

Name	Time	Method
Mean change in systolic blood pressure from baseline	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.
Mean change in diastolic blood pressure from baseline	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.
Mean change in low density lipoprotein	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.
Mean change in fasting blood sugar	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.
Mean change in cholesterol	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.
Mean change in inflammatory biomarker	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.

Secondary Outcome Measures

Name	Time	Method
Mean change in sleep quality score from baseline	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.