Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
Placebo: 50 mg/kg/day during 12 months
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility 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
Sites / Locations
- Hospital Universitario Central de Asturias
- Ramón y Cajal Hospital
- Hospital 12 de Octubre
- Hospital Universitario La Princesa
- Hospital Universitari i Politecnic La FE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Docosahexaenoic acid administration
placebo
Arm Description
50 patients will receive docosahexaenoic acid
50 patients will receive placebo
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01783613
First Posted
January 31, 2013
Last Updated
April 25, 2017
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT01783613
Brief Title
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docosahexaenoic acid administration
Arm Type
Experimental
Arm Description
50 patients will receive docosahexaenoic acid
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
50 patients will receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo: 50 mg/kg/day during 12 months
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Ramón y Cajal Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitari i Politecnic La FE
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33038833
Citation
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.
Results Reference
derived
Learn more about this trial
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
We'll reach out to this number within 24 hrs