Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-02 @ 4:13 AM
Study NCT ID:
NCT01189669
Status:
COMPLETED
Last Update Posted:
2010-09-13
First Post:
2010-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-10', 'studyFirstSubmitDate': '2010-08-24', 'studyFirstSubmitQcDate': '2010-08-26', 'lastUpdatePostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting lipid metabolism', 'timeFrame': 'Following supplementation with LCn-3 PUFA or placebo for 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Plasma hormonal profile', 'timeFrame': 'Following supplementation with LCn-3PUFA or placebo for 6 weeks'}, {'measure': 'Postprandial lipid metabolism', 'timeFrame': 'Following supplementation with LCn-3 PUFA or placebo for 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '21270384', 'type': 'DERIVED', 'citation': "Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26."}]}, 'descriptionModule': {'briefSummary': 'This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.', 'detailedDescription': 'Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.\n* Were between the ages of 18 and 40\n\nExclusion Criteria:\n\n* Were under 18 years or greater than 40 years old,\n* Were non-Caucasian\n* Were pregnant, lactating or trying to conceive\n* Had a body mass index (BMI) \\<18kg/m2 or \\>50kg/m2\n* Had a recent illness or any chronic illness likely to influence results\n* Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents\n* Were taking nutritional supplements\n* Consumed greater than 2 portions of oily fish per week'}, 'identificationModule': {'nctId': 'NCT01189669', 'briefTitle': 'n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'The Adelaide and Meath Hospital'}, 'officialTitle': 'Long Chain (LC) n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS): A Cross-over, Placebo Controlled Dietary Intervention Study', 'orgStudyIdInfo': {'id': 'DDC-UCD-PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LC n-3 PUFA', 'description': 'Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.', 'interventionNames': ['Dietary Supplement: LC n-3 PUFA (fish oil) Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (olive oil) supplement', 'description': '4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.', 'interventionNames': ['Dietary Supplement: Placebo (olive oil) supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Wash out period', 'description': 'A 6 week wash out period separated the LC n-3 PUFA and the Placebo (olive oil) arms. During this period the subjects took no supplements. This arm was designed to minimise a cross-over effect.'}], 'interventions': [{'name': 'LC n-3 PUFA (fish oil) Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['LC n-3 PUFA (fish oil)', 'Placebo (PL)', 'Wash-out (WO)'], 'description': '4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks', 'armGroupLabels': ['LC n-3 PUFA']}, {'name': 'Placebo (olive oil) supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 x 1g olive oil capsules were given daily for 6 weeks', 'armGroupLabels': ['Placebo (olive oil) supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Diabetes Day Centre, The Adelaide and Meath Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '4', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Nutrigenomics Research Group, UCD', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'James Gibney, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Adelaide and Meath Hospital, incorporating The National Children's Hospital"}, {'name': 'Helen M Roche, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Adelaide and Meath Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr James Gibney', 'oldOrganization': "The Adelaide and Meath Hospital Incorporating the National Children's Hospital"}}}}