Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00266305
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2005-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fish Oil Supplementation in Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2008-08-12', 'studyFirstSubmitDate': '2005-12-15', 'studyFirstSubmitQcDate': '2005-12-15', 'lastUpdatePostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast milk fatty acid composition - 0, 2, 4 and 9 mo'}, {'measure': 'Fatty acid composition of infant RBC at 4 mo'}, {'measure': 'Visual acuity - 2 and 4 mo'}, {'measure': 'Follow-up:'}, {'measure': 'Anthropometric measures'}, {'measure': 'Blood pressure'}, {'measure': 'Ex vivo cytokine production (e.g. IL-10 and interferon-γ) in whole blood after 24 h of stimulation with bacterial components'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measures - 0, 2, 4 and 9 mo'}, {'measure': 'Problem solving at 9 mo'}, {'measure': 'Language development (CDI) at 1 and 2 y'}, {'measure': 'Contrast sensitivity at 2 mo'}, {'measure': 'Vernier acuity at 4 mo'}, {'measure': 'Follow-up:'}, {'measure': 'Heart rate variability'}, {'measure': 'Endothelial function measured by PWV'}, {'measure': 'Plasma IgE'}, {'measure': 'Diet'}, {'measure': 'RBC fatty acid composition'}, {'measure': 'Plasma growth factors'}]}, 'conditionsModule': {'keywords': ['n-3 LCPUFA', 'Infant development', 'Visual acuity', 'Immune function', 'Breast milk'], 'conditions': ['Development and Health']}, 'referencesModule': {'references': [{'pmid': '15233397', 'type': 'RESULT', 'citation': 'Lauritzen L, Jorgensen MH, Mikkelsen TB, Skovgaard lM, Straarup EM, Olsen SF, Hoy CE, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on visual acuity and n-3 fatty acid content of infant erythrocytes. Lipids. 2004 Mar;39(3):195-206. doi: 10.1007/s11745-004-1220-8.'}, {'pmid': '16006428', 'type': 'RESULT', 'citation': 'Lauritzen L, Hoppe C, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation and growth during the first 2.5 years of life. Pediatr Res. 2005 Aug;58(2):235-42. doi: 10.1203/01.PDR.0000169978.92437.58. Epub 2005 Jul 8.'}, {'pmid': '15277169', 'type': 'RESULT', 'citation': 'Hoppe C, Udam TR, Lauritzen L, Molgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. doi: 10.1093/ajcn/80.2.447.'}, {'pmid': '15159241', 'type': 'RESULT', 'citation': 'Ulbak J, Lauritzen L, Hansen HS, Michaelsen KF. Diet and blood pressure in 2.5-y-old Danish children. Am J Clin Nutr. 2004 Jun;79(6):1095-102. doi: 10.1093/ajcn/79.6.1095.'}, {'pmid': '16196417', 'type': 'RESULT', 'citation': 'Lauritzen L, Kjaer TM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation of lactating mothers affects cytokine production in 2 1/2-year-old children. Lipids. 2005 Jul;40(7):669-76. doi: 10.1007/s11745-005-1429-6.'}, {'pmid': '16188206', 'type': 'RESULT', 'citation': 'Lauritzen L, Jorgensen MH, Olsen SF, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Reprod Nutr Dev. 2005 Sep-Oct;45(5):535-47. doi: 10.1051/rnd:2005044.'}, {'pmid': '16702318', 'type': 'RESULT', 'citation': 'Larnkjaer A, Christensen JH, Michaelsen KF, Lauritzen L. Maternal fish oil supplementation during lactation does not affect blood pressure, pulse wave velocity, or heart rate variability in 2.5-y-old children. J Nutr. 2006 Jun;136(6):1539-44. doi: 10.1093/jn/136.6.1539.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. A follow-up studies are conducted in order to see if early intake of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily immun function and markers of cardiovascular risk.', 'detailedDescription': 'Background:\n\nStudies indicate that infants, who are fed formula without n-3 LCPUFA, have slower visual development than those, who receive n-3 LCPUFA in breast-milk. The mental development seems also to depend on whether infants are breast-fed or not. Long-term health has also been proposed to be affected (The infant origin of adult disease hypothesis). It is not clear whether these differences is due to dietary LCPUFA as comparison of breast-fed and formula-fed infants are complicated by the socio-demographic differences that exist between mother, who choose to breast-feed or not. Recent studies indicate that LCPUFA supplementation of formulas has beneficial effects on the visual acuity and mental abilities of infants. The LCPUFA content of breast-milk varies and this could potentially be of importance for infant development.\n\nMethods:\n\n211 pregnant women with a high (\\>80 percentile) or low (\\< mean) fish intake were recruited. After birth mother with low fish intake were randomized to receive 4 g/day of fish oil or olive oil for the first 4 months of the lactation period. 150 mother-infant pairs were followed for 1 year gathering information on maternal n-3 LCPUFA intake and infant development (growth, developmental milestones, visual acuity, cognitive functions and language acquisition). Milk samples were collected at 0, 2, 4 and 9 months and blood samples were taken from the mother and the infant at 4 months of age in order to determine the biochemical effect of the supplementation.\n\nThe children were followed-up at 2½ years of age and around 7 years of age. The study is performed in association to the National Birth Cohort.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with uncomplicated singleton pregnancy\n* No metabolic disorders and prepregnancy BMI \\< 30 kg/m2\n* Intention to exclusively breast-feed for 4 mo\n* Fish intake below the Danish mean or above 80th percentile (reference group)\n\nExclusion Criteria:\n\n* Pre- or post term delivery (\\< 37 or \\> 43 wks of gestation)\n* Abnormal weight for gestation (outside 10th-90th percentile range)\n* Apgar score 5 min after delivery \\< 8\n* Infant admission to a neonatal department\n* If supplementation did not begin within 2 wks after delivery'}, 'identificationModule': {'nctId': 'NCT00266305', 'briefTitle': 'Fish Oil Supplementation in Lactation', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'orgStudyIdInfo': {'id': 'KVL-IHE-D72'}, 'secondaryIdInfos': [{'id': 'FØTEK 2: 93s-2468-å96-00020'}, {'id': 'FØTEK 3: 2011-00-0028'}, {'id': 'KF 01-300/98'}, {'id': 'KF 01-183/01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish oil', 'interventionNames': ['Behavioral: Fish oil (Dry n-3, BASF)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil', 'description': 'Control group', 'interventionNames': ['Behavioral: Fish oil (Dry n-3, BASF)']}, {'type': 'NO_INTERVENTION', 'label': 'High fish', 'description': 'Reference group'}], 'interventions': [{'name': 'Fish oil (Dry n-3, BASF)', 'type': 'BEHAVIORAL', 'description': '5 g/oil daily for the first four month of lactation', 'armGroupLabels': ['Fish oil', 'Olive oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Human Nutrition', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Lotte Lauritzen, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Research Agency', 'class': 'OTHER'}, {'name': 'BASF', 'class': 'INDUSTRY'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Associate profesor lotte lauritzen', 'oldOrganization': 'Dept. of Human Nutrition, University of Copenhagen'}}}}