Clinical trial
Melatonin and Essential Arterial Hypertension
Name
NP 2717
Description
Study MIPAE - Melatonin and essential arterial hypertension.
Study with dietary supplement, prospective and monocentric (randomized control trial). 1 mg/day of melatonin has been administered for one year to a group of patients suffering from essential hypertension (from at least one year) and who are already on antihypertensive therapy. This group has been compared with as many hypertensive patients on antihypertensive therapy to whom melatonin has not been administered. Each of the participants have been evaluated at the beginning of the study and after one year considering:
* systolic and diastolic blood pressure;
* echocardiographic values (Vivid Q, GE Healthcare);
* applanation tonometry (SphygmoCor, AtCor Medical);
* peripheral arterial tonometry (EndoPAT-2000, Itamar);
* melatonin levels and total circulating antioxidant capacity after peripheral venous blood sampling.
The aim of the study was to evaluate the antioxidant and vasoprotective effects of melatonin, evaluating both plasma changes and directly studying the possibility of a real remodeling and improvement of cardiac structures.
Trial arms
Trial start
2018-02-02
Estimated PCD
2022-07-14
Trial end
2024-08-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Melatonin
Supplementation with 1 mg/day of melatonin for 1 year
Arms:
Melatonin treated group
Size
23
Primary endpoint
Blood pressure.
Baseline.
Heart rate.
Baseline.
Endothelial parameters.
Baseline.
Arterial stiffness parameters.
Baseline.
Echocardiographic parameters.
Baseline.
Plasmatic melatonin levels.
Baseline.
Total circulating antioxidant capacity in plasma.
Baseline.
Blood pressure.
1 year.
Heart rate.
1 year.
Endothelial parameters.
1 year.
Arterial stiffness parameters.
1 year.
Echocardiographic parameters.
1 year.
Plasmatic melatonin levels.
1 year.
Total circulating antioxidant capacity in plasma.
1 year.
Eligibility criteria
Inclusion Criteria:
* Caucasian race;
* Age 40-50;
* Signed written informed consent
* Normal weight;
* Blood pressure: PAD \>90 mmHg and PAS \>140 mmHg;
* Blood pressure in the above mentioned range from at least 1 years
* Fasting blood sugar \< 100 mg/dL;
* Total cholesterol \< 200 mg/dL and triglycerides \< 150 mg/dL;
* Intake of antihypertensive therapies (except nitrates, statins and β-blockers);
* Non-smoking;
* No night shift workers (at least in the last 3 months before recruitment);
* With a regular sleep/wake rhythm;
* No pregnant/nursing women.
Exclusion Criteria:
* Blood pressure: PAD \<90 mmHg and PAS \<140 mmHg
* Heart disease of any kind;
* Autoimmune or rheumatological or vascular diseases other than essential hypertension;
* Anti-hypertensive therapies with nitrates, statins or β-blockers;
* Pregnancy/nursing;
* \< 40 or \> 50 years;
* Worker with night shifts (for a period of less than 3 months before recruitment);
* Continuous irregular sleep/wake rhythm.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-02-01
1 organization
1 product
1 indication
Product
MelatoninIndication
Hypertension