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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01783613
First received: January 31, 2013
Last updated: April 14, 2015
Last verified: January 2015
  Purpose

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 Intervention 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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 96
Study Start Date: October 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783613

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

No publications provided

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
Study First Received: January 31, 2013
Last Updated: April 14, 2015
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on May 28, 2015