A Triple Blinded Randomized Controlled Trial of Oral Melatonin in Elevated Blood Pressure Individual (MRCTEBP)
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 320
- Primary Endpoint
- Mean change in systolic blood pressure from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Triple blinding is planned. All participants, medical providers and outcome evaluators will be blinded about treatment arms.
The THC pharmacy will dispense the medication and perform the randomization. Melatonin capsule and placebo will be completely identical.
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Melatonin
Intervention group1:
Melatonin,capsule,3 mg, one dose one hour before bedtime, three weeks
Intervention: Melatonin/experimental (Drug)
Placebo
Intervention group2 :
Placebo, capsule, 3 mg, one dose one hour before bedtime, for three weeks
Intervention: Placebo oral capsule/placebo comparator (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Mean change in sleep quality score from baseline(From enrollment to end of treatment at 3 weeks)
Investigators
Zinat Hatmi
Professor
Tehran University of Medical Sciences