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

NCT01783613 | Completed

• 1 other identifier: Docosahexaenoic acid
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (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

  12 months

Study Arms (2)

Docosahexaenoic acid administration

EXPERIMENTAL

50 patients will receive docosahexaenoic acid

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

placebo

PLACEBO COMPARATOR

50 patients will receive placebo

Dietary Supplement: Placebo: 50 mg/kg/day during 12 months

Interventions

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

Docosahexaenoic acid administration

Placebo: 50 mg/kg/day during 12 months DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 2 Months - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed of cystic fibrosis over than 2 months age
• Tolerance clinical supplementation with DHA
• Clinical situation stable

You may not qualify if:

• Changes in the routine treatment in the 2 weeks prior to baseline

Sponsors & Collaborators

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

Study Sites (5)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Ramón y Cajal Hospital

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Universitari i Politecnic La FE

Valencia, 46026, Spain

Location

Related Publications (1)

• Lopez-Neyra A, Suarez L, Munoz M, de Blas A, Ruiz de Valbuena M, Garriga M, Calvo J, Ribes C, Giron Moreno R, Maiz L, Gonzalez D, Bousono C, Manzanares J, Pastor O, Martinez-Botas J, Del Campo R, Canton R, Roy G, Menacho M, Arroyo D, Zamora J, Soriano JB, Lamas A. Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Nov;162:102186. doi: 10.1016/j.plefa.2020.102186. Epub 2020 Oct 1.

  PMID: 33038833 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: October 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2015-01

Locations

ES (5)