- ICH GCP
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- Ensaio 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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 Placebo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
neurological and cognitive development of the offspring
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
- Diretor de estudo: Berthold Koletzko, Prof., Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01111
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