Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)

Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02690857

Acronym

OMEGAMUCO

Enrollment

Registered

2016-02-24

Start date

2010-05-31

Completion date

Unknown

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief 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. 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.

Interventions

DRUGDocosahexaenoic acid

DRUGSunflower Oil

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

6 Years to 30 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in 8-isoprostane level in urine.	Day 14	Measured by urinalysis (Immunoassay).

Secondary

Measure	Time frame	Description
Change in 11-dehydro-thromboxane B2 in urine.	Day 28	Measured by urinalysis (Immunoassay).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Day 28	Measured by vital signs
Change in percent predicted forced expiratory volume in 1 second	from baseline through Day 28	Spirometry
Evaluation of the effect of DHA on specific biomarkers.	Day 28	Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026