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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: Docosahexaenoic acid
* Drug: Sunflower Oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docosahexaenoic acid<br>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). | Drug: Docosahexaenoic acid<br> <br> |
| Placebo Comparator: Sunflower oil<br>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. | Drug: Sunflower Oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 8-isoprostane level in urine. | Measured by urinalysis (Immunoassay). | Day 14 | 

Secondary Outcome Measures

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