Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 3:07 PM
Study NCT ID:
NCT00678067
Status:
COMPLETED
Last Update Posted:
2008-05-19
First Post:
2008-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'C050055', 'term': 'wheat germ oil'}, {'id': 'D004035', 'term': 'Diet Therapy'}], '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': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, '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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2008-05-08', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypercholesterolemic children', 'Docosahexaenoic acid', 'Eicosapentaenoic acid', 'Blood lipid profile'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '24228803', 'type': 'DERIVED', 'citation': 'Verduci E, Agostoni C, Radaelli G, Banderali G, Riva E, Giovannini M. Blood lipids profile in hyperlipidemic children undergoing different dietary long chain polyunsaturated supplementations: a preliminary clinical trial. Int J Food Sci Nutr. 2014 May;65(3):375-9. doi: 10.3109/09637486.2013.858239. Epub 2013 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'To examine whether Docosahexaenoic Acid (DHA) and Docosahexaenoic + Eicosapentaenoic Acids (DHA+EPA) supplementation in addition to National Cholesterol Education Program Step I Diet in Hypercholesterolemic Children increases Docosahexaenoic Acid (DHA) plasma levels in the 2 intervention groups versus placebo. Secondary outcome measure: effect of DHA and DHA+EPA supplementation on blood lipid profile', 'detailedDescription': 'In a double-blind placebo-controlled trial 36 hypercholesterolemic children, 3-13 years of age, 19 males and 17 females were put on National Cholesterol Education Program (NCEP)Step-I diet and randomised into 3 groups to receive 500 mg/day of purified Docosahexaenoic Acid (DHA), Docosahexaenoic Acid plus Eicosapentaenoic Acid (DHA+EPA) mixture (228 + 208 mg/day respectively), or wheat germ oil as placebo. They underwent at baseline and after a 4 month treatment: EPA and DHA levels in total plasma and in phospholipids, triglycerides, cholesteryl esters; dietary habits by food frequency questionnaire; blood lipid profile (total cholesterol, HDL cholesterol, triglycerides levels)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of primary hypercholesterolemia (total cholesterol levels \\> 200 mg/dl before entering the study)\n* BMI \\>3°and \\< 97° percentile for age\n* First referring to our Lipid Clinic\n\nExclusion Criteria:\n\n* Secondary dyslipidemia\n* Obesity\n* Step I diet or any dietary supplement before entering the study'}, 'identificationModule': {'nctId': 'NCT00678067', 'acronym': 'DHA-RICHOIL', 'briefTitle': 'Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Effects of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid(EPA)Supplementation on DHA Plasmatic Status and Blood Lipid Profile in Hypercholesterolemic Children in Addition to National Cholesterol Education Program Step I Diet', 'orgStudyIdInfo': {'id': 'DHA-RICH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '12 hypercholesterolemic children 3-13 years of age', 'interventionNames': ['Dietary Supplement: Germ oil', 'Other: National Cholesterol Education Program (NCEP) Step I Diet']}, {'type': 'EXPERIMENTAL', 'label': 'DHA+EPA group', 'description': '12 hypercholesterolemic children 3-13 years of age', 'interventionNames': ['Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)', 'Other: National Cholesterol Education Program (NCEP) Step I Diet']}, {'type': 'EXPERIMENTAL', 'label': 'DHA Group', 'description': '12 hypercholesterolemic children 3-13 years of age', 'interventionNames': ['Dietary Supplement: Docosahexaenoic acid', 'Other: National Cholesterol Education Program (NCEP) Step I Diet']}], 'interventions': [{'name': 'Docosahexaenoic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['DHA'], 'description': 'Soft capsules 500 mg/each; 1 capsule/day for 4 months', 'armGroupLabels': ['DHA Group']}, {'name': 'Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['DHA and EPA mixture'], 'description': 'Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months', 'armGroupLabels': ['DHA+EPA group']}, {'name': 'Germ oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['wheat germ oil'], 'description': 'Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months', 'armGroupLabels': ['Placebo']}, {'name': 'National Cholesterol Education Program (NCEP) Step I Diet', 'type': 'OTHER', 'otherNames': ['Dietary intervention', 'Dietary recommendations'], 'description': 'Dietary counselling aimed at achieving NCEP Dietary Guidelines: Total fat intake \\<30% of total calories, Saturated fat intake \\<10% of total calories, Polyunsaturated fat intake up to 10% of total calories, monounsaturated fat intake 10-15% of total calories', 'armGroupLabels': ['DHA Group', 'DHA+EPA group', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Silvia Decarlis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Silvia Decarlis, MD', 'oldOrganization': 'Dept. of Pediatrics, San Paolo Hospital, University of Milan, Italy'}}}}