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

NCT01783613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-04-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

Placebo: 50 mg/kg/day during 12 months

Sponsors & Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783613 on ClinicalTrials.gov