Status:
UNKNOWN
Study MIPAE - Melatonin and Essential Arterial Hypertension
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Essential Hypertension
Eligibility:
All Genders
40-50 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Hypertension is a pathological condition characterized by a constant and not occasional increase in systolic and diastolic blood pressure values. This pathology represents one of the most important pu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05257291
Start Date
February 2 2018
End Date
August 1 2024
Last Update
February 1 2023
Active Locations (1)
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1
Anatomy and Physiopathology Division, Department of Experimental and Clinical Sciences, University of Brescia (Italy), Viale Europa 11, 25123 Brescia, Italy
Brescia, Italy, 23125