The study evaluates the effects of different forms of folates on cardiovascular risk factors in postmenopausal patients MedDRA version: 14.1 Level: PT Classification code 10051775 Term: Postmenopause System Organ Class: 10041244 - Social circumstances
Conditions
Sponsors
ZAMBON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Postmenopausal women with age between 45 and 55 at screening; - Women with plasmatic folate levels not superior than 5 ng/ml as assessed in the screening visit; -Women who have no intention of taking hormone replacement therapy -; -BMI between 19 and 30; -Good physical health and mental health; -Willingness to sign the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Severe hypertension therapy. -Patients who smoke -Presence or history of significant liver disease until the liver function tests are not back to normal; -Presence or history of liver tumors (benign or malignant); -Malignant neoplasms, known or suspected; -Hypersensitivity to the active substance or excipients of the drug under study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of two different forms of folate on blood pressure at night and 24 hours in a group of postmenopausal women;Secondary Objective: evaluate, in a group of postmenopausal women, the effect of two different forms of folate: - Endothelium dependent vasodilator response, - Insulin resistance (HOMA-IR), - Red blood cells and serum levels of the different types of folate, - homocysteine;Primary end point(s): To evaluate the effect of two different forms of folate on blood pressure at night and 24 hours in a group of postmenopausal women. Based on preliminary data, we can expect a difference of 4.5 mm Hg pressure in the night average of women treated with 5-MTHF and about 1 mm Hg in the group treated with folic acid.;Timepoint(s) of evaluation of this end point: Blood pressure (at night and 24 hours) is measured at baseline and after 3 weeks of treatment with different types of folate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): evaluate, in a group of postmenopausal women, the effect of two different forms of folate: - Endothelium dependent vasodilator response, - Insulin resistance (HOMA-IR), - Red blood cells and serum levels of the different types of folate, - homocysteine;Timepoint(s) of evaluation of this end point: Secondary endpoints ware measured at baseline and after 3 weeks of treatment with different types of folate. | — |
Countries
Italy
Contacts
Public Contactdivisione di emmedi srl
SOLARIS
Outcome results
None listed