Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-03 @ 9:58 PM
Study NCT ID:
NCT02690857
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 8-isoprostane level in urine.', 'timeFrame': 'Day 14', 'description': 'Measured by urinalysis (Immunoassay).'}], 'secondaryOutcomes': [{'measure': 'Change in 11-dehydro-thromboxane B2 in urine.', 'timeFrame': 'Day 28', 'description': 'Measured by urinalysis (Immunoassay).'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Day 28', 'description': 'Measured by vital signs'}, {'measure': 'Change in percent predicted forced expiratory volume in 1 second', 'timeFrame': 'from baseline through Day 28', 'description': 'Spirometry'}, {'measure': 'Evaluation of the effect of DHA on specific biomarkers.', 'timeFrame': 'Day 28', 'description': 'Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).'}]}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '27914512', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \\> 60 mmol/L and a pancreatic insufficiency.\n* Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years\n* Body weight \\> 26 kg\n* Stable CF disease as judged by the investigator.\n* Subjects must have an Forced Expiratory Volume at one second \\> 40 % of predicted normal for age, sex and height at the screening visit.\n* Subjects should not have enteral or parenteral nutrition.\n* No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.\n\nExclusion Criteria:\n\n* Subjects with cirrhosis and portal hypertension.\n* Subjects with Cystic fibrosis related diabetes.\n* Concomitant participation in another clinical study.\n* Known allergy or intolerance to the active principle.\n* Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).\n* Subjects on a transplant waiting list.'}, 'identificationModule': {'nctId': 'NCT02690857', 'acronym': 'OMEGAMUCO', 'briefTitle': 'Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '2008.533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docosahexaenoic acid', '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.\n\nSubjects 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).', 'interventionNames': ['Drug: Docosahexaenoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sunflower oil', '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.', 'interventionNames': ['Drug: Sunflower Oil']}], 'interventions': [{'name': 'Docosahexaenoic acid', 'type': 'DRUG', 'armGroupLabels': ['Docosahexaenoic acid']}, {'name': 'Sunflower Oil', 'type': 'DRUG', 'armGroupLabels': ['Sunflower oil']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}