Back to resultsEffect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
Primary Purpose
Cystic Fibrosis in Children
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)
PLACEBO (OLIVE OIL)
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis in Children focused on measuring cystic fibrosis, Docosahexaenoic Acid, fatty acids
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
Sites / Locations
- Parc Tauli Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antioxidant docosahexaenoic acid (DHA)
Placebo
Arm 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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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)
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.
Change from baseline fecal calprotectin at the 12 months
Calprotectin was measured in fecal samples of the participants.
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.
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).
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.
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.
Change from baseline height at 3, 6, 9 and 12 months
Height was measured with a standardised statdiometer every 3months
Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months
BMI was calculate every 3 months.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04987567
Brief Title
Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
Official Title
Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis in Children
Keywords
cystic fibrosis, Docosahexaenoic Acid, fatty acids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Is not a drug, is a food supplement.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind study
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant docosahexaenoic acid (DHA)
Arm Type
Active Comparator
Arm 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)
Intervention Description
Pearls of DHA (BrudyNen)
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO (OLIVE OIL)
Intervention Description
Pearls manufactured to mimic DHA (BrudyNen).
Primary Outcome Measure Information:
Title
Change from Baseline Fatty Acid (FA) profile (percentage) of the erythrocyte membrane at 6 and 12 months
Description
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 Outcome Measure Information:
Title
Change from Baseline Serum interleukins at 12 months
Description
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)
Title
Change from baseline pulmonary function at 3,6 ,9 and 12 months
Description
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)
Title
Number of Pulmonary exacerbation during the study year compared with previous years
Description
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
Title
Change from baseline fecal calprotectin at the 12 months
Description
Calprotectin was measured in fecal samples of the participants.
Time Frame
Baseline and 12 months
Title
Adverse reactions during the study
Description
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)
Title
Change from Baseline Esputum interleukins at 6 and 12 months
Description
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
Title
Change from baseline differencial cell counts in sputum at 6 and 12 months.
Description
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
Title
Change from baseline weight at 3, 6, 9 and 12 months
Description
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
Title
Change from baseline height at 3, 6, 9 and 12 months
Description
Height was measured with a standardised statdiometer every 3months
Time Frame
Baseline, 3,6,9 and 12 months
Title
Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months
Description
BMI was calculate every 3 months.
Time Frame
Baseline, 3,6,9 and 12 months
Title
Change from Baseline FA ratios of the erythrocyte membrane at 6 and 12 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roser Ayats Vidal, MD
Organizational Affiliation
Parc Tauli Hospital from Sabadell (Barcelona). Spain.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Tauli Hospital
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
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