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- Ensayo clínico NCT00266305
Fish Oil Supplementation in Lactation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
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.
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Frederiksberg, Dinamarca, DK-1958
- Department of Human Nutrition
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pregnant women with uncomplicated singleton pregnancy
- 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:
- Pre- or post term delivery (< 37 or > 43 wks of gestation)
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Aceite de pescado
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5 g/oil daily for the first four month of lactation
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Comparador de placebos: Olive oil
Control group
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5 g/oil daily for the first four month of lactation
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Sin intervención: High fish
Reference group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Presión sanguínea
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Breast milk fatty acid composition - 0, 2, 4 and 9 mo
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Fatty acid composition of infant RBC at 4 mo
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Visual acuity - 2 and 4 mo
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Follow-up:
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Anthropometric measures
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Ex vivo cytokine production (e.g. IL-10 and interferon-γ) in whole blood after 24 h of stimulation with bacterial components
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Medidas de resultado secundarias
Medida de resultado |
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Variabilidad del ritmo cardíaco
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Follow-up:
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Anthropometric measures - 0, 2, 4 and 9 mo
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Problem solving at 9 mo
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Language development (CDI) at 1 and 2 y
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Contrast sensitivity at 2 mo
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Vernier acuity at 4 mo
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Endothelial function measured by PWV
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IgE plasmática
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Dieta
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RBC fatty acid composition
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Plasma growth factors
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KVL-IHE-D72
- FØTEK 2: 93s-2468-å96-00020
- FØTEK 3: 2011-00-0028
- KF 01-300/98
- KF 01-183/01
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