Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months

Dietary Supplement: Placebo: 50 mg/kg/day during 12 months

Study type

Interventional

Funder types

Other

Identifiers

NCT01783613

Docosahexaenoic acid

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

2 months to 100 years old

Volunteers

No Healthy Volunteers

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