Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 8:39 PM
Study NCT ID:
NCT01180933
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2010-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Oil and Folate Supplementation During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood', 'timeFrame': 'labour', 'description': 'the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter'}], 'secondaryOutcomes': [{'measure': 'neurological and cognitive development of the offspring', 'timeFrame': 'age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years', 'description': 'non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring'}, {'measure': 'weight development', 'timeFrame': 'age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years', 'description': 'body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined'}, {'measure': 'height', 'timeFrame': 'age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years', 'description': 'body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years'}, {'measure': 'life style and diet', 'timeFrame': 'age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years', 'description': 'information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)'}, {'measure': 'electroencephalography (EEG)', 'timeFrame': 'age 8 years and 9.5 years', 'description': 'at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['docosahexaenoic acid', 'folate', 'neurological development', 'allergies', 'long term consequences for the offspring', 'allergy risk'], 'conditions': ['Perinatal DHA and Folate Status', 'Neurological Development']}, 'referencesModule': {'references': [{'pmid': '17490978', 'type': 'RESULT', 'citation': 'Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392.'}, {'pmid': '26561619', 'type': 'DERIVED', 'citation': 'Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11.'}, {'pmid': '21849596', 'type': 'DERIVED', 'citation': 'Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17.'}, {'pmid': '21525247', 'type': 'DERIVED', 'citation': 'Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.\n\nNon invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy\n* gestation \\<20 week at enrollment\n* intention to deliver in one of the study centers\n* body weight at time of enrollment from 50 kg to 92 kg\n\nExclusion Criteria:\n\n* serious chronic illness (eg, diabetes, hepatitis)\n* use fish oil supplements since the beginning of pregnancy\n* use of folate or vitamin B-12 supplements after gestation week 16'}, 'identificationModule': {'nctId': 'NCT01180933', 'acronym': 'NUHEAL', 'briefTitle': 'Fish Oil and Folate Supplementation During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy', 'orgStudyIdInfo': {'id': '01111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fish oil', 'description': 'the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery', 'interventionNames': ['Dietary Supplement: fish oil']}, {'type': 'EXPERIMENTAL', 'label': 'folate', 'description': 'the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery', 'interventionNames': ['Dietary Supplement: folate']}, {'type': 'EXPERIMENTAL', 'label': 'fish oil + folate', 'description': 'the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery', 'interventionNames': ['Dietary Supplement: fish oil + folate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 mg of DHA and 150 mg of eicosapentaenoic acid per day', 'armGroupLabels': ['fish oil']}, {'name': 'folate', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 µg per day', 'armGroupLabels': ['folate']}, {'name': 'fish oil + folate', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day', 'armGroupLabels': ['fish oil + folate']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'only vitamins and minerals as recommended, but no fish oil or folate', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80337', 'city': 'Munich', 'country': 'Germany', 'facility': 'Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '7623', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Department of Paediatrics, University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Berthold Koletzko, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Berthold Koletzko', 'oldOrganization': 'Ludwig-Maximilians University of Munich'}}}}