Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
1998-12-31
2007-01-31
Brief Summary
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Detailed Description
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Studies 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.
Methods:
211 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.
The 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Fish oil
Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation
Olive oil
Control group
Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation
High fish
Reference group
No interventions assigned to this group
Interventions
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Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation
Eligibility Criteria
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Inclusion Criteria
* No metabolic disorders and prepregnancy BMI \< 30 kg/m2
* Intention to exclusively breast-feed for 4 mo
* Fish intake below the Danish mean or above 80th percentile (reference group)
Exclusion Criteria
* Abnormal weight for gestation (outside 10th-90th percentile range)
* Apgar score 5 min after delivery \< 8
* Infant admission to a neonatal department
* If supplementation did not begin within 2 wks after delivery
FEMALE
Yes
Sponsors
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Danish Research Agency
OTHER
BASF
INDUSTRY
Technical University of Denmark
OTHER
University of Copenhagen
OTHER
Responsible Party
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Dept. of Human Nutrition, University of Copenhagen
Principal Investigators
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Lotte Lauritzen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
Locations
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Department of Human Nutrition
Frederiksberg, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FØTEK 2: 93s-2468-å96-00020
Identifier Type: -
Identifier Source: secondary_id
FØTEK 3: 2011-00-0028
Identifier Type: -
Identifier Source: secondary_id
KF 01-300/98
Identifier Type: -
Identifier Source: secondary_id
KF 01-183/01
Identifier Type: -
Identifier Source: secondary_id
KVL-IHE-D72
Identifier Type: -
Identifier Source: org_study_id