Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-03-16 @ 7:15 PM
Study NCT ID:
NCT01742468
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2012-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a)', 'timeFrame': '10 weeks', 'description': 'Cardiovascular risk factors'}], 'primaryOutcomes': [{'measure': 'Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7', 'timeFrame': '10 weeks', 'description': 'Disease activity parameters'}], 'secondaryOutcomes': [{'measure': 'Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan', 'timeFrame': '10 weeks', 'description': 'Further disease acitvity parameters'}, {'measure': 'Concentrations of arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid in plasma lipids and erythrocyte lipids', 'timeFrame': '10 weeks', 'description': 'Precursors of eicosanoids (leukotriens, prostaglandins, thromboxanes) and docosanoids (resolvines)'}, {'measure': 'Lipid mediators formed by lipoxygenases, cyclogenases', 'timeFrame': '10 weeks', 'description': 'Lipidmediators derived from arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['n-3 LC-PUFA, DHA, rheumatoid arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28302406', 'type': 'DERIVED', 'citation': 'Dawczynski C, Dittrich M, Neumann T, Goetze K, Welzel A, Oelzner P, Volker S, Schaible AM, Troisi F, Thomas L, Pace S, Koeberle A, Werz O, Schlattmann P, Lorkowski S, Jahreis G. Docosahexaenoic acid in the treatment of rheumatoid arthritis: A double-blind, placebo-controlled, randomized cross-over study with microalgae vs. sunflower oil. Clin Nutr. 2018 Apr;37(2):494-504. doi: 10.1016/j.clnu.2017.02.021. Epub 2017 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA supplemented products (sausage, tomato spread, milk beverage) on disease activity, inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.', 'detailedDescription': 'Recent studies suggest that the daily intake of n-3 LC-PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) can support the therapy of chronic-inflammatory diseases and might be useful to prevent coronary heart diseases. The majority of these studies do not differentiate between the effects of EPA and DHA. The present study investigate the therapeutic potential of DHA in patients with rheumatoid arthritis.\n\nAs a precondition for participating in this study, the patients were provided information in writing and verbally form about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all patients were subject to a medical examination by their general rheumatologist. Thirty-eight patients with rheumatoid arthritis (DAS ≥ 2.4) entered the study.\n\nThe placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between (after the washout period the intervention was crossed between the groups and the respective products were consumed for further 10 weeks).\n\nPatients in the placebo period receive 60 g sausage, 8 g tomato spread and 30 g milk powder (= 200 mL milk beverage) daily. These products were enriched with sunflower oil (8 g/d).\n\nIn the intervention period, the products (60 g sausage, 8 g tomato spread and 30 g milk powder (= 200 mL milk beverage) were enriched with 8 g microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany). In this group, the daily dose of docosahexaenoic acid (DHA) amounted to 2.11 g.\n\nVenous blood is collected at the beginning and at the end of each period.\n\n• Disease activity was determined by sum of tender and swollen joints (68/66), joint score DAS28, ultrasound score (US-7 score), rheumascan, inflammatory markers (ESR, C reactive protein), HAQ questionnaire and further lifestyle forms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a diagnosis of RA (according to the ACR classification criteria, revised 2010) for at least 6 months prior to randomization.\n* Patient has a moderate disease activity as defined by disease activity score DAS28 ≥ 2.4\n* Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.\n* stable dosis of disease-modifying antirheumatic drugs within 4 weeks prior to randomization and presumably over the study periods (30 weeks).\n\nExclusion Criteria:\n\n* Intra-articular corticosteroids within 4 weeks prior to randomization or blood sample taking\n* Patients are permitted to receive either oral or parenteral glucocorticoids equivalent to ≤10 mg daily prednisone and nonsteroidal anti-inflammatory drug, if they have received a stable dose for at least 4 weeks prior to randomization and presumably over the study periods (30 weeks).'}, 'identificationModule': {'nctId': 'NCT01742468', 'briefTitle': 'Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status', 'orgStudyIdInfo': {'id': 'H53-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary supplement: n-3 LC-PUFA', 'description': 'Name: microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany; rich in docosahexaenoic acid (DHA); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder', 'interventionNames': ['Dietary Supplement: long-chain n-3 PUFA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dietary supplement: sunflower oil', 'description': 'Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder', 'interventionNames': ['Dietary Supplement: sunflower oil']}], 'interventions': [{'name': 'long-chain n-3 PUFA', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['n-3 LC-PUFA'], 'description': 'Dietary supplement: n-3 LC-PUFA = Microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany (rich in docosahexaenoic acid (DHA)); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: included in 60 g sausage, 8 g tomato spread, 30 g milk powder', 'armGroupLabels': ['Dietary supplement: n-3 LC-PUFA']}, {'name': 'sunflower oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['placebo'], 'description': 'Dietary supplement: sunflower oil Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder', 'armGroupLabels': ['Dietary supplement: sunflower oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Friedrich Schiller University, Clinic for Internal Medicine', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Gerhard Jahreis, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena, Department of Nutritional Physiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Jahreis', 'investigatorAffiliation': 'University of Jena'}}}}