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

Civil Hospices of Lyon

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Sunflower Oil; Drug: Docosahexaenoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02690857

2008.533

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Docosahexaenoic acid

Experimental group

Description:

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).

Treatment:

Drug: Docosahexaenoic acid

Sunflower oil

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sunflower Oil