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

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Civil Hospices of Lyon

Status and phase

Completed
Phase 2

Conditions

Cystic Fibrosis

Treatments

Drug: Docosahexaenoic acid
Drug: Sunflower Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT02690857
2008.533

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

6 to 30 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups, including a placebo group

Docosahexaenoic acid
Experimental group
Description:
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).
Treatment:
Drug: Docosahexaenoic acid
Sunflower oil
Placebo Comparator group
Description:
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.
Treatment:
Drug: Sunflower Oil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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