Cystic Fibrosis
Conditions
Brief summary
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.
Interventions
DIETARY_SUPPLEMENTDocosahexaenoic acid administration: 50 mg/kg/day during 12 months
DIETARY_SUPPLEMENTPlacebo: 50 mg/kg/day during 12 months
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 100 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed of cystic fibrosis over than 2 months age * Tolerance clinical supplementation with DHA * Clinical situation stable
Exclusion criteria
* Changes in the routine treatment in the 2 weeks prior to baseline * Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo | 12 months |
Countries
Spain
Outcome results
None listed