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

Not Applicable

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT01783613
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitari i Politecnic La FE; 🇪🇸 Valencia, Spain

Ramón y Cajal Hospital; 🇪🇸 Madrid, Spain