Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-14 @ 8:20 AM
Study NCT ID:
NCT02062528
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hot Flashes and Omega 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hot flashes frequency', 'timeFrame': '1 to 8 week', 'description': 'ANOVA by repeated measures'}], 'secondaryOutcomes': [{'measure': 'hot flashes frequency difference', 'timeFrame': '4 week and 8 week', 'description': 'difference betwwen week8 and week4 and week0'}, {'measure': 'diurnal hot flashes', 'timeFrame': 'week 1 to 8', 'description': 'ANOVA and difference'}, {'measure': 'night hot flashes', 'timeFrame': 'week 1 to 8', 'description': 'ANOVA and difference'}, {'measure': 'vasomotors disorders', 'timeFrame': 'week 1 to week 8', 'description': 'ANOVA and differences'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'week 0 and week 8', 'description': 'sleep quality'}, {'measure': 'HFRDIS', 'timeFrame': 'week 0 and week 8', 'description': 'quality of life'}, {'measure': 'The Menopause-Specific Quality of Life (MENQOL)', 'timeFrame': 'week 0 and week 8', 'description': 'quality of life'}, {'measure': 'Weight', 'timeFrame': 'week 0 and week 8'}, {'measure': 'fatty acids dosage', 'timeFrame': 'week 0 and week 8', 'description': 'fatty acids dosage'}, {'measure': 'number of adverse events', 'timeFrame': 'week 0 to week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EPA'], 'conditions': ['Hot Flashes', 'Fatty Acids', 'Menopause']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* menopause or peri menopause\n* complaining of hot flashes\n* social security affiliation\n* informed consent form signed\n\nExclusion Criteria:\n\n* primary pathology which can lead to hot flashes\n* allergy to omega-3 fatty acids\n* allergy to sea products\n* High consumption of fat fish or produced by the sea\n* iatrogenic hot flashes\n* actual omega-3 fatty acids consumption or in the 3 last months.\n* consumption of drug or other products for hot flashes in the last month\n* protected persons (L1121-5 to L1121-8 of French Public health code)'}, 'identificationModule': {'nctId': 'NCT02062528', 'acronym': 'BOOM3', 'briefTitle': 'Hot Flashes and Omega 3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vivatech'}, 'officialTitle': "Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo", 'orgStudyIdInfo': {'id': 'DCIC 13 15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'omega-3 fatty acids', 'description': '3 capsules each day during 8 weeks', 'interventionNames': ['Dietary Supplement: omega-3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '3 capsules each day during 8 weeks', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'omega-3 fatty acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['groupe actif'], 'description': 'highly dosed in EPA', 'armGroupLabels': ['omega-3 fatty acids']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble Cedex9', 'country': 'France', 'facility': "Centre d'investigation clinique CIC1406"}], 'overallOfficials': [{'name': 'Jean-Luc CRACOWSKI, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'investigation clinique CIC1406"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivatech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Centre d'Investigation Clinique de Grenoble CIC1406", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}