Cystic FibrosisNCT01783613
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
A study testing Docosahexaenoic acid administration: 50 mg/kg/day during 12 months in people with Cystic Fibrosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
Trial summary
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad… Read more about this study
- Who is it for?
- Ages 2 months to 100 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Docosahexaenoic acid administration: 50 mg/kg/day during 12 months
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 5 sitesSpain
- Study dates
- Oct 2011to Jan 2015
- 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 2 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed of cystic fibrosis over than 2 months age
- Tolerance clinical supplementation with DHA
- Clinical situation stable
Who cannot join
- Changes in the routine treatment in the 2 weeks prior to baseline
- Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Ramón y Cajal Hospital
Madrid, 28034
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Princesa
Madrid
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Universitari i Politecnic La FE
Valencia, 46026
About this study
Official title: Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.
- Conditions
- Cystic Fibrosis
- Being tested
- Docosahexaenoic acid administration: 50 mg/kg/day during 12 months, Placebo: 50 mg/kg/day during 12 months
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid administration: 50 mg/kg/day during 12 monthsDietary supplement
Placebo: 50 mg/kg/day during 12 monthsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic acid administration | Experimental | 50 patients will receive docosahexaenoic acid Receives: Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months |
| placebo | Placebo comparator | 50 patients will receive placebo Receives: Dietary Supplement: Placebo: 50 mg/kg/day during 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783613
- Sponsor's protocol ID
- Docosahexaenoic acid
- Status last verified
- Jan 2015
- First submitted
- 31 Jan 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Neyra A, Suarez L, Munoz M, de Blas A, Ruiz de Valbuena M, Garriga M, Calvo J, Ribes C, Giron Moreno R, Maiz L, Gonzalez D, Bousono C, Manzanares J, Pastor O, Martinez-Botas J, Del Campo R, Canton R, Roy G, Menacho M, Arroyo D, Zamora J, Soriano JB, Lamas A. Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Nov;162:102186. doi: 10.1016/j.plefa.2020.102186. Epub 2020 Oct 1.
PubMed 33038833
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01783613
- Acronym / sponsor ID
- Docosahexaenoic acid
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- 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.
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic acid administration | Experimental | Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months50 patients will receive docosahexaenoic acid |
| placebo | Placebo comparator | Dietary Supplement: Placebo: 50 mg/kg/day during 12 months50 patients will receive placebo |
Who may qualify
- Ages
- 2 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed of cystic fibrosis over than 2 months age
- Tolerance clinical supplementation with DHA
- Clinical situation stable
Key exclusion criteria (2 listed)
- Changes in the routine treatment in the 2 weeks prior to baseline
- Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion
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 |
|---|---|---|
| Docosahexaenoic acid administration: 50 mg/kg/day during 12 months | Dietary supplement | Docosahexaenoic acid administration |
| Placebo: 50 mg/kg/day during 12 months | Dietary supplement | placebo |
Primary outcome
To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo
Time frame: 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 26 Apr 2017.
- Derived from this study: PubMed 33038833Lopez-Neyra A, Suarez L, Munoz M, de Blas A, Ruiz de Valbuena M, Garriga M, Calvo J, Ribes C, Giron Moreno R, Maiz L, Gonzalez D, Bousono C, Manzanares J, Pastor O, Martinez-Botas J, Del Campo R, Canton R, Roy G, Menacho M, Arroyo D, Zamora J, Soriano JB, Lamas A. Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Nov;162:102186. doi: 10.1016/j.plefa.2020.102186. Epub 2020 Oct 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid administration: 50 mg/kg/day during 12 months in people with Cystic Fibrosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites 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 3 inclusion and 2 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783613, which also lists 1 linked publication.
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 26 Apr 2017.