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

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ClinicalTrials.gov Identifier: NCT01783613
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months Dietary Supplement: Placebo: 50 mg/kg/day during 12 months Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
Study Start Date : October 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   2 Months to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783613


Locations
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Ramón y Cajal Hospital
Madrid, Spain, 28034
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitari i Politecnic La FE
Valencia, Spain, 46026
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01783613     History of Changes
Other Study ID Numbers: Docosahexaenoic acid
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: January 2015

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases