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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783613
• Other study ID #: Docosahexaenoic acid
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: April 25, 2017
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

• Placebo: 50 mg/kg/day during 12 months

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Ramón y Cajal Hospital	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitari i Politecnic La FE	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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