NCT02690857

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
Last Updated

May 28, 2019

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

February 16, 2016

Last Update Submit

May 23, 2019

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Change in 8-isoprostane level in urine.

    Measured by urinalysis (Immunoassay).

    Day 14

Secondary Outcomes (4)

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

    Day 28

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

    Day 28

  • Change in percent predicted forced expiratory volume in 1 second

    from baseline through Day 28

  • Evaluation of the effect of DHA on specific biomarkers.

    Day 28

Study Arms (2)

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).

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.

Drug: Sunflower Oil

Interventions

Docosahexaenoic acidDRUG
Docosahexaenoic acid
Sunflower OilDRUG
Sunflower oil

Eligibility Criteria

Age6 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27914512RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Docosahexaenoic AcidsSunflower Oil

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

February 24, 2016

Study Start

May 1, 2010

Primary Completion

May 1, 2010

Last Updated

May 28, 2019

Record last verified: 2016-02