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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2010-020516-11-IT
Date of registration:	28/09/2010
Prospective Registration:	No
Primary sponsor:	AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Public title:	EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - ND
Scientific title:	EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - ND
Date of first enrolment:	16/09/2010
Target sample size:
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020516-11
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: integratore alimentare
Phase:

Countries of recruitment
Italy

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- male and female at the age >= 7 and <= 14 - cystic fibrosis patients - pancreatic insufficiency - FEV1 > 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:
- 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CYSTIC FIBROSIS AND PANCREATIC INSUFFICIENCY
MedDRA version: 9.1 Level: PT Classification code 10033628
MedDRA version: 9.1 Level: PT Classification code 10011762

Intervention(s)

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)
Concentration type: equal
Concentration number: 15-

Trade Name: INDUSIL*OS GTT FL 30MG+FL 15ML
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Cobamamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary ID(s)

CRCFC-DHA002

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
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