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

April 25, 2017 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Ramón y Cajal Hospital
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Princesa
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docosahexaenoic acid administration
50 patients will receive docosahexaenoic acid
Dietary supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
Placebo Comparator: placebo
50 patients will receive placebo
Dietary supplement: Placebo: 50 mg/kg/day during 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Docosahexaenoic acid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe