- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Aberdeen, Royaume-Uni, AB25 2ZN
- Aberdeen Maternity Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
Délai: 1 year
|
1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Dietary vitamin E intake during pregnancy.
Délai: 1 year
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1 year
|
|
Lung function of new born infants.
Délai: 1 year
|
1 year
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Biomarker of dietary compliance
Délai: 1 year
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Graham Devereux, MD, University of Aberdeen
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies du système immunitaire
- Maladies pulmonaires
- Hypersensibilité immédiate
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité
- Asthme
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents protecteurs
- Micronutriments
- Vitamines
- Antioxydants
- Vitamine E
Autres numéros d'identification d'étude
- 2/0036/12
- 12/NS/0053 (Autre identifiant: North of Scotland Research Ethics Service)
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