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

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Docosahexaenoic acid; Drug: Sunflower Oil

• Registration Number: NCT02690857
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-05
• Status Verified: 2016-02
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Docosahexaenoic acid	Docosahexaenoic acid	Each capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid. Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods).
Sunflower oil	Sunflower Oil	Placebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days.

Primary Outcome Measures

Name	Time	Method
Change in 8-isoprostane level in urine.	Day 14	Measured by urinalysis (Immunoassay).

Secondary Outcome Measures

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