E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study evaluates the effects of different forms of folates on cardiovascular risk factors in postmenopausal patients |
Lo studio valuta gli effetti delle diverse forme di folati sui fattori di rischio cardiovascolare di pazienti in postmenopausa |
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E.1.1.1 | Medical condition in easily understood language |
The study evaluates the effects of different forms of folates on cardiovascular risk factors in postmenopausal patients |
Lo studio valuta gli effetti delle diverse forme di folati sui fattori di rischio cardiovascolare di pazienti in postmenopausa |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051775 |
E.1.2 | Term | Postmenopause |
E.1.2 | System Organ Class | 10041244 - Social circumstances |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of two different forms of folate on blood pressure at night and 24 hours in a group of postmenopausal women |
Valutare l’effetto di due diverse forme di folati sulla pressione arteriosa notturna e delle 24 ore in un gruppo di donne in post-menopausa |
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E.2.2 | Secondary objectives of the trial |
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 |
valutare,in un gruppo di donne in postmenopausa,l’effetto di due diverse forme di folati su :- risposta vasodilatatoria endotelio dipendente,- insulino resistenza (HOMA-IR),- livelli sierici ed intraeritrocitari dei vari tipi di folati,- omocisteinemia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
-Donne in postmenopausa di età compresa tra i 45 e i 55 anni al momento dello screening; - Donne con livelli di folati plasmatici accertati alla visita di screening non superiori ai 5 ng/ml; -Donne che non abbiano intenzione di assumere terapia ormonale sostitutiva; -BMI compreso tra 19 e 30; -Buono stato di salute fisico e mentale; -Disponibilità a firmare il modulo per il consenso informato. |
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E.4 | Principal 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. |
-Ipertensione severa in terapia. -Pazienti fumatrici -Presenza o storia di importanti patologie epatiche fino a che i valori di funzionalità epatica non siano di nuovo nella norma; -Presenza o storia di neoplasie epatiche (benigne o maligne); -Neoplasie maligne, note o sospette; -Ipersensibilità verso il principio attivo o gli eccipienti dei farmaci oggetto dello studio. |
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E.5 End points |
E.5.1 | 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. |
Valutare l’effetto di due diverse forme di folati sulla pressione arteriosa notturna e delle 24 ore in un gruppo di donne in post-menopausa. Sulla base di dati preliminari, ci si può aspettare una differenza di 4.5 mm Hg nella pressione notturna media delle donne trattate con 5-MTHF e di circa 1 mm Hg nel gruppo trattato con Acido Folico |
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E.5.1.1 | 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. |
La pressione arteriosa (notturna e delle 24 ore) è misurata in condizioni basali e dopo 3 settimane di trattamento con i diversi tipi di folato. |
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E.5.2 | 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 |
valutare, in un gruppo di donne in postmenopausa, l’effetto di due diverse forme di folati su : - risposta vasodilatatoria endotelio dipendente, - insulino resistenza (HOMA-IR), - livelli sierici ed intraeritrocitari dei vari tipi di folati, - omocisteinemia |
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E.5.2.1 | 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. |
Gli endpoint secondari sono misurati in condizioni basali e dopo 3 settimane di trattamento con i diversi tipi di folato. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 14 |