Reduction of the overomocisteinemie MedDRA version: 9.1 Level: LLT Classification code 10051286 Term: Hyperhomocysteinaemia
Conditions
Interventions
Trade Name: CITOFOLIN 10 CPR 15 MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Calcium folinate
CAS Number: 1492-18-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients subordinates to transplant of liver from at least 6 months with advanced levels of total plasmatic omocisteine over to 15 mmol/L, decided to accept to join voluntarily to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients subordinates to transplant of liver from at least 6 months that they do not accept to join to the voluntary study and patients who have one contraindication to the supplement with folic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: If the supplement with folic acid to hyperphysiological doses is in a position to reducing the levels of omocisteine in the patients subordinates to liver transplant.;Secondary Objective: to verify if the reduction of the levels of omocisteine is in a position to reducing the number of cardiovascular events.;Primary end point(s): determination of the levels of plasmatic omocisteine and of folic acid | — |
Countries
Italy
Outcome results
None listed