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

NCT04987567 | Completed DMC

• 1 other identifier: PED-DHA-FQ
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children

Keywords

cystic fibrosis; Docosahexaenoic Acid; fatty acids

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Fatty Acid (FA) profile (percentage) of the erythrocyte membrane at 6 and 12 months

  After blood sampling, erythrocytes are separated from the plasma by centrifugation (2500 rpm for 15 min) and stored at -80ºC until analysed. The fatty acids composition are analyzed by gas chromatography. Fatty acid composition (SFA (saturated FA), MUFA (monoinsatured FA), PUFAs N-6 (polyunsaturated FA omega-6) and PUFAS N-3) are mesured as percentage of total fats.

  baseline, 6 month and 12 month of treatment (end of study)

Secondary Outcomes (11)

• Change from Baseline Serum interleukins at 12 months

  baseline and 12 month of treatment (end of study)

• Change from baseline pulmonary function at 3,6 ,9 and 12 months

  baseline, 3 months, 6 month, 9 months and 12 month of treatment (end of study)

• Number of Pulmonary exacerbation during the study year compared with previous years

  12 months prior study, 12 months of the study

• Change from baseline fecal calprotectin at the 12 months

  Baseline and 12 months

• Adverse reactions during the study

  baseline, 3, 6 , 9 and 12 month of treatment (end of study)

Study Arms (2)

Antioxidant docosahexaenoic acid (DHA)

ACTIVE COMPARATOR

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).

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

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: PLACEBO (OLIVE OIL)

Interventions

ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®) DIETARY_SUPPLEMENT

Pearls of DHA (BrudyNen)

Antioxidant docosahexaenoic acid (DHA)

PLACEBO (OLIVE OIL) DIETARY_SUPPLEMENT

Pearls manufactured to mimic DHA (BrudyNen).

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Be already supplementing with Omega -3, fish oil or DHA

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Parc Tauli Hospital

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Roser Ayats Vidal, MD

  Parc Tauli Hospital from Sabadell (Barcelona). Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Is not a drug, is a food supplement.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 3, 2021
• Study Start: March 21, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: August 3, 2021

Record last verified: 2021-06

Locations

ES (1)