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Completed

NCT Number: NCT04987567

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

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.

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Key information

Conditions

Cystic Fibrosis in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc Tauli Hospital

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

Dietary Supplement

Pearls of DHA (BrudyNen)

Placebo (olive oil)

Dietary Supplement

Pearls manufactured to mimic DHA (BrudyNen).

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Change from Baseline Serum interleukins at 12 months

    Time frame: baseline and 12 month of treatment (end of study)

    Serum are obtained by centrifugation of blood samples and frozen at -80ºC until testing.

    Interleukins (IL)-1 β, IL-6, IL-8 and tumor necrosis factor (TNF)-α (pg/ml) are analized in serum by enzyme-linked immunosorbent assay (ELISA kits).

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

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

    Forced expiratory volume in 1 second (FEV1) , forced vital capacity (FVC) and 25-75% of the forced vital capacity (FEF25-75%) were mesured using spirometry, calibrated daily according to standardized techniques.

    The results are expressed as the mean value of the percentage of predicted values according to height and sex and litres (L)

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

    Time frame: 12 months prior study, 12 months of the study

    The investigators will report the number of pulmonary exacerbations during the previous year and the year of the study. To calculate the number of exacerbations, the medical records of the patients will be reviewed.

  4. Change from baseline fecal calprotectin at the 12 months

    Time frame: Baseline and 12 months

    Calprotectin was measured in fecal samples of the participants.

  5. Adverse reactions during the study

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

    Frequency of occurrence of adverse events related to the study treatment: diarrhea, steatorrhea, abdominal pain, nausea, vomiting, gastroesophageal reflux, fishy taste or hemorrhage.

  6. Change from Baseline Esputum interleukins at 6 and 12 months

    Time frame: baseline and 12 months

    Supernatant induced sputum were frozen at -80ºC until testing. Induced sputum Interleukins (IL)-1 β, IL-6, IL-8 and tumor necrosis factor (TNF)-α (pg/ml) were analized by enzyme-linked immunosorbent assay (ELISA kits).

  7. Change from baseline differencial cell counts in sputum at 6 and 12 months.

    Time frame: baseline, 6 months and 12 monts

    An equal volume of sterile dithiothreitol (DTT), freshly diluted to 10% by the addition of sterile saline, was added to the sputum. This step was performed under a Bio-safety hood using sterile technique. The samples were then incubated in a shaking water bath at 37° C for 5-10 min, and gently mixed using a transfer pipette at 5-min intervals. The weight of the remaining sputum mixture was measured, and a further three times the volume of both DTT and phosphate-buffered saline (Dulbecco's; Gibco BRL, Grand Island, NY) were added. The mixture was incubated once again in the 37° C shaking water bath for another 5-10 min to ensure complete homogenization. Ten microliters of the homogenized sputum samples, mixed with Trypan Blue stain, was used to calculate total cell counts, using a standard hemacytometer. A further 0.25-0.50 ml of both samples was used to prepare cytospin slides for differential cell counts.

  8. Change from baseline weight at 3, 6, 9 and 12 months

    Time frame: Baseline, 3,6,9 and 12 months

    Weight in kilograms (kg) were measured every 3 months. Subjects dressed only in light underwear and shoeless.

  9. Change from baseline height at 3, 6, 9 and 12 months

    Time frame: Baseline, 3,6,9 and 12 months

    Height was measured with a standardised statdiometer every 3months

  10. Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months

    Time frame: Baseline, 3,6,9 and 12 months

    BMI was calculate every 3 months.

  11. Change from Baseline FA ratios of the erythrocyte membrane at 6 and 12 months

    Time frame: baseline, 6 months and 12 months

    The next fatty acids (FA) ratios were calculated:

    Arachidonic acid /eicosapentaenoic acid (ARA/EPA) Arachidonic acid/ docosahexaenoic acid (ARA/DHA) N-3 PUFAS/ALA ( α-linolenic acid) N-6 PUFAS/LA (linoleic acid)

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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