Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients

Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial

This study evaluates the effect of antioxidant docosahexaenoic acid (DHA) in patients with cystic fibrosis. Half of participants will receive DHA, while the other half will receive placebo.

Several studies show that patients with cystic fibrosis (CF) usually have, compared to the normal population, low levels of linoleic acid (LA) and docosahexaenoic acid (DHA) and increase in arachidonic acid (AA), which is pro-inflammatory. Normalization or modification of this fatty acid pattern (AP) could reduce chronic inflammation. The aim of this study is to assess the effect of oral supplementation with DHA for one year in pediatric patients (6-18 years) with CF, on inflammatory parameters, AP profile, lung function (spirometry) and number of exacerbations.

Inclusion Criteria:

• Patients of both genders with a diagnosis of cystic fibrosis.
• FEV1 > 40%.
• Age between 6 and 18 years.
• Patients who grant their informed consent or whose representative grants informed consent to participate in the study.

Exclusion Criteria:

• Pregnant or breastfeeding women
• Basal oxygen saturation <92% or household supplemental oxygen needs.
• Massive hemoptysis
• Patients who are not able to follow or who cannot be assessed in the study according to the protocol.
• Any circumstance that, at the discretion of the doctor, may involve a clinical risk or harm, the patient's participation in the study or that interferes with the evaluation of the same.
• Use of systemic glucocorticoids or in the 4 weeks prior to inclusion in the study.
• Use of non-steroidal anti-inflammatory drugs in the 2 weeks prior to inclusion in the study.
• Use of investigational drugs or participation in another clinical trial within 30 days prior to inclusion in the study or within the 5 elimination half-lives of the investigational drug.
• Be already supplementing with Omega -3, fish oil or DHA