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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Change in 8-isoprostane level in urine.
Measured by urinalysis (Immunoassay).
Time frame: Day 14
Change in 11-dehydro-thromboxane B2 in urine.
Measured by urinalysis (Immunoassay).
Time frame: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured by vital signs
Time frame: Day 28
Change in percent predicted forced expiratory volume in 1 second
Spirometry
Time frame: 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).
Time frame: Day 28
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