Cystic FibrosisPhase 2OMEGAMUCONCT02690857
Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)
A Phase 2 study testing Docosahexaenoic acid and Sunflower Oil in people with Cystic Fibrosis, run by Hospices Civils de Lyon.
Trial summary
Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status. Read more about this study
- Who is it for?
- Ages 6 to 30 years, men only
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Docosahexaenoic acid and Sunflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2010
- Phase
- Phase 2
- 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 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L and a pancreatic insufficiency.
- Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
- Body weight > 26 kg
- Stable CF disease as judged by the investigator.
- Subjects must have an Forced Expiratory Volume at one second > 40 % of predicted normal for age, sex and height at the screening visit.
- Subjects should not have enteral or parenteral nutrition.
- No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.
Who cannot join
- Subjects with cirrhosis and portal hypertension.
- Subjects with Cystic fibrosis related diabetes.
- Concomitant participation in another clinical study.
- Known allergy or intolerance to the active principle.
- Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
- Subjects on a transplant waiting list.
About this study
Official title: Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis
Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.
In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.
- Conditions
- Cystic Fibrosis
- Being tested
- Docosahexaenoic acid, Sunflower Oil
- 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 acidDrug
Sunflower OilDrug
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic acid | Experimental | Each capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid.
Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods). Receives: Drug: Docosahexaenoic acid |
| Sunflower oil | Placebo comparator | Placebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days. Receives: Drug: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 8-isoprostane level in urine.
Measured by urinalysis (Immunoassay).
Measured: Day 14
Secondary outcomes (4)
Change in 11-dehydro-thromboxane B2 in urine.
Measured by urinalysis (Immunoassay).
Measured: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured by vital signs
Measured: Day 28
Change in percent predicted forced expiratory volume in 1 second
Spirometry
Measured: from baseline through Day 28
Evaluation of the effect of DHA on specific biomarkers.
Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMay 2010
- Primary completionMay 2010
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690857
- Sponsor's protocol ID
- 2008.533
- Acronym
- OMEGAMUCO
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2016
- Last updated
- 28 May 2019
- Results posted
- No
Publications
Vericel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18.
PubMed 27914512
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02690857
- Acronym / sponsor ID
- OMEGAMUCO / 2008.533
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- First posted
- 24 Feb 2016 (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.
Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.
In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic acid | Experimental | Drug: Docosahexaenoic acidEach capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid. Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods). |
| Sunflower oil | Placebo comparator | Drug: Sunflower OilPlacebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L and a pancreatic insufficiency.
- Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
- Body weight > 26 kg
- Stable CF disease as judged by the investigator.
- Subjects must have an Forced Expiratory Volume at one second > 40 % of predicted normal for age, sex and height at the screening visit.
Key exclusion criteria (6 listed)
- Subjects with cirrhosis and portal hypertension.
- Subjects with Cystic fibrosis related diabetes.
- Concomitant participation in another clinical study.
- Known allergy or intolerance to the active principle.
- Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
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 | Drug | Docosahexaenoic acid |
| Sunflower Oil | Drug | Sunflower oil |
Primary outcome
Change in 8-isoprostane level in urine.
Time frame: Day 14
Measured by urinalysis (Immunoassay).
4 secondary outcomes
Change in 11-dehydro-thromboxane B2 in urine.
Time frame: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Day 28
Change in percent predicted forced expiratory volume in 1 second
Time frame: from baseline through Day 28
Evaluation of the effect of DHA on specific biomarkers.
Time frame: Day 28
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 28 May 2019.
- Results publication: PubMed 27914512Vericel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docosahexaenoic acid and Sunflower Oil in people with Cystic Fibrosis, run by Hospices Civils de Lyon.
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 7 inclusion and 6 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in 8-isoprostane level in urine. (time frame: Day 14). 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 NCT02690857, 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 28 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.