Cystic Fibrosis in ChildrenNCT04987567
Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
A study testing ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®) in people with Cystic Fibrosis in Children, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2018to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial
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.
Read the 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
- Being tested
- ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®), PLACEBO (OLIVE OIL)
- Keywords
- cystic fibrosis, Docosahexaenoic Acid, fatty acids
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)Dietary supplement
Pearls of DHA (BrudyNen)
PLACEBO (OLIVE OIL)Dietary supplement
Pearls manufactured to mimic DHA (BrudyNen).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: PLACEBO (OLIVE OIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 month and 12 month of treatment (end of study)
Secondary outcomes (11)
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).
Measured: baseline and 12 month of treatment (end of study)
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)
Measured: 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
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.
Measured: 12 months prior study, 12 months of the study
Change from baseline fecal calprotectin at the 12 months
Calprotectin was measured in fecal samples of the participants.
Measured: Baseline and 12 months
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.
Measured: baseline, 3, 6 , 9 and 12 month of treatment (end of study)
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).
Measured: baseline and 12 months
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.
Measured: baseline, 6 months and 12 monts
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.
Measured: Baseline, 3,6,9 and 12 months
Change from baseline height at 3, 6, 9 and 12 months
Height was measured with a standardised statdiometer every 3months
Measured: Baseline, 3,6,9 and 12 months
Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months
BMI was calculate every 3 months.
Measured: Baseline, 3,6,9 and 12 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)
Measured: baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start21 Mar 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Is not a drug, is a food supplement.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roser Ayats-Vidal, Corporacion Parc Tauli
- Investigators
- Roser Ayats Vidal, MD, Principal investigator, Parc Tauli Hospital from Sabadell (Barcelona). Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987567
- Sponsor's protocol ID
- PED-DHA-FQ
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04987567
- Acronym / sponsor ID
- PED-DHA-FQ
- Conditions
- Cystic Fibrosis in Children
- Keywords
- cystic fibrosis, Docosahexaenoic Acid, fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Is not a drug, is a food supplement.
| Arm | Type | Receives |
|---|---|---|
| Antioxidant docosahexaenoic acid (DHA) | Active comparator | Dietary Supplement: ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)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). |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBO (OLIVE OIL)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). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)Pearls of DHA (BrudyNen) | Dietary supplement | Antioxidant docosahexaenoic acid (DHA) |
| PLACEBO (OLIVE OIL)Pearls manufactured to mimic DHA (BrudyNen). | Dietary supplement | Placebo |
Primary outcome
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.
11 secondary outcomes
Change from Baseline Serum interleukins at 12 months
Time frame: baseline and 12 month of treatment (end of study)
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)
Number of Pulmonary exacerbation during the study year compared with previous years
Time frame: 12 months prior study, 12 months of the study
Change from baseline fecal calprotectin at the 12 months
Time frame: Baseline and 12 months
Adverse reactions during the study
Time frame: baseline, 3, 6 , 9 and 12 month of treatment (end of study)
Change from Baseline Esputum interleukins at 6 and 12 months
Time frame: baseline and 12 months
Change from baseline differencial cell counts in sputum at 6 and 12 months.
Time frame: baseline, 6 months and 12 monts
Change from baseline weight at 3, 6, 9 and 12 months
Time frame: Baseline, 3,6,9 and 12 months
Change from baseline height at 3, 6, 9 and 12 months
Time frame: Baseline, 3,6,9 and 12 months
Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months
Time frame: Baseline, 3,6,9 and 12 months
Change from Baseline FA ratios of the erythrocyte membrane at 6 and 12 months
Time frame: baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roser Ayats Vidal, MD principal investigator
Parc Tauli Hospital from Sabadell (Barcelona). Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®) in people with Cystic Fibrosis in Children, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.