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

NCT ID: NCT04987567

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2020-02-20

Brief Summary

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.

Detailed 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.

Conditions

Cystic Fibrosis in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Antioxidant docosahexaenoic acid (DHA)

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).

Group Type: ACTIVE_COMPARATOR

ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

Intervention Type: DIETARY_SUPPLEMENT

Pearls of DHA (BrudyNen)

Placebo

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).

Group Type: PLACEBO_COMPARATOR

PLACEBO (OLIVE OIL)

Intervention Type: DIETARY_SUPPLEMENT

Pearls manufactured to mimic DHA (BrudyNen).

Interventions

ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

Pearls of DHA (BrudyNen)

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO (OLIVE OIL)

Pearls manufactured to mimic DHA (BrudyNen).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Roser Ayats-Vidal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roser Ayats Vidal, MD

Role: PRINCIPAL_INVESTIGATOR

Parc Tauli Hospital from Sabadell (Barcelona). Spain.

Locations

Parc Tauli Hospital

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

PED-DHA-FQ

Identifier Type: -

Identifier Source: org_study_id