Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)

Cystic Fibrosis Clinical Trial

— OMEGAMUCO  

Official title:

Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690857
• Other study ID #: 2008.533
• Status: Completed
• Phase: Phase 2
• Start date: May 2010

Study information

• Verified date: February 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.

In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 30 Years

Eligibility

Inclusion Criteria:

• Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L and a pancreatic insufficiency.

• Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years

• Body weight > 26 kg

• Stable CF disease as judged by the investigator.

• Subjects must have an Forced Expiratory Volume at one second > 40 % of predicted normal for age, sex and height at the screening visit.

• Subjects should not have enteral or parenteral nutrition.

• No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.

Exclusion Criteria:

• Subjects with cirrhosis and portal hypertension.

• Subjects with Cystic fibrosis related diabetes.

• Concomitant participation in another clinical study.

• Known allergy or intolerance to the active principle.

• Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).

• Subjects on a transplant waiting list.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Docosahexaenoic acid

• Sunflower Oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

References & Publications (1)

Véricel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 8-isoprostane level in urine.	Measured by urinalysis (Immunoassay).	Day 14
Secondary	Change in 11-dehydro-thromboxane B2 in urine.	Measured by urinalysis (Immunoassay).	Day 28
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Measured by vital signs	Day 28
Secondary	Change in percent predicted forced expiratory volume in 1 second	Spirometry	from baseline through Day 28
Secondary	Evaluation of the effect of DHA on specific biomarkers.	Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).	Day 28