CYSTIC FIBROSIS AND PANCREATIC INSUFFICIENCY MedDRA version: 9.1 Level: PT Classification code 10033628 MedDRA version: 9.1 Level: PT Classification code 10011762
Conditions
Interventions
Trade Name: PREFOLIC*30CPR GASTROR 15MG
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Detoxifying agents for antineoplastic treatment
Concentration unit: mg milligram(s)
Concentrat
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female at the age >= 7 and 60% - The patients have to able to effect a spirometry in reproduced way - The parents or the legal tutors have to written the consent to study participation before of whatever procedure Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients with meconium ileal history - pancreatic sufficient - FEV1<60% - Intravenous antibiotic therapy during the three month before the Visit 1 (V1) - Patients with epilepsy history: the folic acid at high dose can reduce the antiepileptic effect of fenobarbital, fenitoin and primidone - Nutritional state < 5? percentile of weight and/or height (defined of WHO tablets) - Altered renal or hepatic function (AST and ALT levels 5 times upper of normal levels, creatinine 2 times upper of normal levels) - Transplantation history or waiting-list patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the DHA increase in patients plasma treated with DHA and 5-MTHF + Vit. B12 and with DHA;Secondary Objective: 1. To evaluate the change in fat acids profile in the patients blood treated with DHA and 5-MTHF + Vit. B12 and with DHA 2. To evaluate the membrane fluidity in blood cells 3. To evaluate the change in levels of inflammation protein markers in plasma and blood 4. To evaluate the auxometric parameters and pulmonary functionality 5. To evaluate serum levels of LDL, HDL, cholesterol and TG, in the different experimental conditions and in the different estimated times;Primary end point(s): To evaluate the DHA levels in patients plasma treated with DHA and 5-MTHF + Vit. B12 and with DHA . Moreover will be evaluated the fat acids profile in the blood, the inflammation protein in the plasma, the membrane fluidity in the monocities, the seric lipid parameters. Furthermore will be record the patient’s diet of 72 with the aim to exclude eventually interferences for the intake of foods rich oh DHA, folic acid and B12 vitamin | — |
Countries
Italy
Outcome results
None listed