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Completed

NCT Number: NCT02690857

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docosahexaenoic Acid

Drug

Sunflower Oil

Drug

Primary outcomes

  1. Change in 8-isoprostane level in urine.

    Time frame: Day 14

    Measured by urinalysis (Immunoassay).

Secondary outcomes

  1. Change in 11-dehydro-thromboxane B2 in urine.

    Time frame: Day 28

    Measured by urinalysis (Immunoassay).

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Day 28

    Measured by vital signs

  3. Change in percent predicted forced expiratory volume in 1 second

    Time frame: from baseline through Day 28

    Spirometry

  4. Evaluation of the effect of DHA on specific biomarkers.

    Time frame: Day 28

    Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: OMEGAMUCO

Important dates

Study start
2010
Primary completion
2010
First posted
Feb 24, 2016
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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