NCT01783613

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

Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 2 Months – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
DIETARY_SUPPLEMENT	Placebo: 50 mg/kg/day during 12 months

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-02-05
• Last updated: 2017-04-26

Locations

5 sites across 1 country: Spain