- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01180933
Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)
Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
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.
Non 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- singleton pregnancy
- gestation <20 week at enrollment
- intention to deliver in one of the study centers
- body weight at time of enrollment from 50 kg to 92 kg
Exclusion Criteria:
- serious chronic illness (eg, diabetes, hepatitis)
- use fish oil supplements since the beginning of pregnancy
- use of folate or vitamin B-12 supplements after gestation week 16
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: fish oil
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
|
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
|
Experimental: folate
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
|
400 µg per day
|
Experimental: fish oil + folate
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
|
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
|
Comparador de placebos: placebo
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
|
only vitamins and minerals as recommended, but no fish oil or folate
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
Periodo de tiempo: labour
|
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
|
labour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
neurological and cognitive development of the offspring
Periodo de tiempo: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
|
non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring
|
age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
|
weight development
Periodo de tiempo: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
|
body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined
|
age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
|
height
Periodo de tiempo: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
|
body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
|
age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
|
life style and diet
Periodo de tiempo: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
|
information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)
|
age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
|
electroencephalography (EEG)
Periodo de tiempo: age 8 years and 9.5 years
|
at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests
|
age 8 years and 9.5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Berthold Koletzko, Prof., Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01111
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