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

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

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.

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.