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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Docosahexaenoic acid administration

50 patients will receive docosahexaenoic acid

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

placebo

50 patients will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo: 50 mg/kg/day during 12 months

Intervention Type DIETARY_SUPPLEMENT

Interventions

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

Intervention Type DIETARY_SUPPLEMENT

Placebo: 50 mg/kg/day during 12 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No