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

Corporacion Parc Tauli

Status: Completed

Conditions: Cystic Fibrosis in Children

Treatments: Dietary Supplement: PLACEBO (OLIVE OIL); Dietary Supplement: ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04987567

PED-DHA-FQ

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Antioxidant docosahexaenoic acid (DHA)

Active Comparator group

Description:

Antioxidant docosahexaenoic acid (Tridocosahexaenoin-AOX ® 70%) 50mg/kg/day: 50mg/kg/day so: * \> = 13-17kg: 2 pearls (700mg DHA) every day, once or twice daily (od or bd) * \> = 18-24kg: 3 pearls (1050mg DHA) every day, od or bd * \> = 25-30kg: 4 pearls (1400mg DHA) every day, bd (2-0-2) * \> = 31-36kg: 5 pearls (1750mg DHA) every day, bd (2-0-3) * \> = 37-43kg: 6 pearls (2100mg DHA) every day, bd (3-0-3) * \> = 44-49kg: 7 pearls (2450mg DHA) every day, three times a day (td) (3-1-3) * \> = 50kg: 8 prearls (2800mg DHA) every day, td (3-2-3).

Treatment:

Dietary Supplement: ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

Placebo

Placebo Comparator group

Description:

Olive oil 50mg/kg/day so: * \> = 13-17kg: 2 pearls every day, once or twice daily (od or bd) * \> = 18-24kg: 3 pearls every day, od or bd * \> = 25-30kg: 4 pearls every day, bd (2-0-2) * \> = 31-36kg: 5 pearls every day, bd (2-0-3) * \> = 37-43kg: 6 pearls every day, bd (3-0-3) * \> = 44-49kg: 7 pearls every day, three times a day (td) (3-1-3) * \> = 50kg: 8 prearls every day, td (3-2-3).

Treatment:

Dietary Supplement: PLACEBO (OLIVE OIL)