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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon

Criteria

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.