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

NCT ID: NCT02690857

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Docosahexaenoic acid

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Sunflower Oil

Intervention Type: DRUG

Interventions

Docosahexaenoic acid

Intervention Type: DRUG

Sunflower Oil

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Vericel 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;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18.

Reference Type: RESULT

PMID: 27914512 (View on PubMed)

Other Identifiers

2008.533

Identifier Type: -

Identifier Source: org_study_id