- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01661530
Piloting a Dietary Vitamin E Intervention During Pregnancy
A Double Blind Randomised Placebo Controlled Pilot Study of a Dietary Soup Intervention During Pregnancy to Optimise Dietary Vitamin E Intake in Relation to Childhood Asthma.
In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma.
However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy reduces the risk of childhood asthma. We are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin E intake to the recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary intervention using vitamin E in its natural form of food is more likely to be successful and acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women can optimise their vitamin E intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. With commercial support we have developed a range of soups containing foods naturally rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of similar tasting and looking placebo soups has also been developed. In this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin E intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin E intake during pregnancy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Aberdeen, Reino Unido, AB25 2ZN
- Aberdeen Maternity Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 10-12 weeks pregnant.
- Routine low risk antenatal care.
- A personal or partner history of asthma at anytime.
- Able and willing to give informed consent to participate
- Able and willing to participate in the study procedures
Exclusion Criteria:
- Use of vitamin E supplements.
- A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants.
- Any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study.
- Participating in another clinical study
- Previous allocation of randomisation code in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Vitamin E enhanced diet
Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form.
Three portions per week
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vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
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Comparador de placebos: Non-enhanced dietary intervention
Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content.
Three portions per week
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Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
Periodo de tiempo: 1 year
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Dietary vitamin E intake during pregnancy.
Periodo de tiempo: 1 year
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1 year
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Lung function of new born infants.
Periodo de tiempo: 1 year
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1 year
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Biomarker of dietary compliance
Periodo de tiempo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Graham Devereux, MD, University of Aberdeen
Publicaciones y enlaces útiles
Publicaciones Generales
- Devereux G, Turner SW, Craig LC, McNeill G, Martindale S, Harbour PJ, Helms PJ, Seaton A. Low maternal vitamin E intake during pregnancy is associated with asthma in 5-year-old children. Am J Respir Crit Care Med. 2006 Sep 1;174(5):499-507. doi: 10.1164/rccm.200512-1946OC. Epub 2006 Jun 8.
- Litonjua AA, Rifas-Shiman SL, Ly NP, Tantisira KG, Rich-Edwards JW, Camargo CA Jr, Weiss ST, Gillman MW, Gold DR. Maternal antioxidant intake in pregnancy and wheezing illnesses in children at 2 y of age. Am J Clin Nutr. 2006 Oct;84(4):903-11. doi: 10.1093/ajcn/84.4.903.
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
- Enfermedades de las vías respiratorias
- Enfermedades del sistema inmunológico
- Enfermedades pulmonares
- Hipersensibilidad, Inmediata
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad
- Asma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes Protectores
- Micronutrientes
- Vitaminas
- Antioxidantes
- Vitamina e
Otros números de identificación del estudio
- 2/0036/12
- 12/NS/0053 (Otro identificador: North of Scotland Research Ethics Service)
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