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

Browse trials for

• Cystic Fibrosis 1,581
• Fibrosis 3,255

Keywords

• cystic fibrosis
• Docosahexaenoic Acid
• fatty acids

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 22 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Study arms

• Active comparator
  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).

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

• Placebo comparator
  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).

  Dietary Supplement: PLACEBO (OLIVE OIL)

Interventions

• Dietary supplementANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

  Pearls of DHA (BrudyNen)

• Dietary supplementPLACEBO (OLIVE OIL)

  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

   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.

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

Secondary outcomes

1. Change from Baseline Serum interleukins at 12 months

   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).

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

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

   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)

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

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

   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.

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

4. Change from baseline fecal calprotectin at the 12 months

   Calprotectin was measured in fecal samples of the participants.

   Time frame: Baseline and 12 months

5. Adverse reactions during the study

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

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

6. Change from Baseline Esputum interleukins at 6 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).

   Time frame: baseline and 12 months

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

   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.

   Time frame: baseline, 6 months and 12 monts

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

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

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

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

   Height was measured with a standardised statdiometer every 3months

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

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

    BMI was calculate every 3 months.

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

11. Change from Baseline FA ratios of the erythrocyte membrane at 6 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)

    Time frame: baseline, 6 months and 12 months