- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01779180
Vitamin A Supplementation at Birth and Atopy in Childhood
The Effect of Vitamin A Supplementation at Birth on the Development of Atopy in Childhood: Long-term Follow-up of a Randomised Placebo-controlled Trial
INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation (NVAS) have been reported, and another four are underway to test whether NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of NVAS on atopy and wheezing was found (manuscript under review).
Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS is associated with a higher risk of atopy and wheezing. The investigators therefore aim to conduct a similar follow-up study of participants in the first NVAS trial conducted in Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is associated with an increased risk of atopy and wheezing and other allergic symptoms as well as growth.
METHODS
Study population:
From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns when they came for BCG vaccination. Provided parental consent, they received an oral supplement of 50,000 IU vitamin A or placebo.
Study design:
This study will be a follow-up study of the cohort of children randomised to NVAS (intervention) or placebo (current policy) together with BCG vaccine at birth.
Other exposures:
The investigators will also investigate the effect of receiving an additional dose of measles vaccine and the timing of DTP vaccine on the development of atopy.
Assessment of outcomes:
The investigators will visit all children at the last known address. Height, weight and mid upper arm circumference will be measured. BCG scar will be examined and vaccination card details recorded by the field assistant. Children will be excluded from skin prick testing (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine medication. SPT will be performed using aero-allergens, food allergens and positive histamine and negative saline control. The mother or guardian will be interviewed by a local assistant. Symptoms of eczema and asthma as well as food allergy will be assessed.
Statistical analysis:
Effect of randomisation group and other factors on outcomes will be analysed in multivariable regression models. All analyses will be adjusted for skin prick tester. All analyses will be conducted stratified by sex.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Bissau Codex
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Bissau, Bissau Codex, Guinée-Bissau, 1004
- Bandim Health Project
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Enrolled at birth in NCT00168610
Exclusion Criteria:
- Children with history suggestive of anaphylaxis will be excluded from skin prick testing but included in the study population
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Atopic sensitisation
Délai: Single observation on day of recruitment
|
Skin prick test positivity.
A wheal >=3mm will be considered positive.
|
Single observation on day of recruitment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Symptoms of asthma
Délai: Single observation on day of recruitment
|
Questionnaire based on ISAAC survey for 6-7 year olds
|
Single observation on day of recruitment
|
Symptoms of eczema
Délai: Single observation on day of recruitment
|
Questionnaire based on ISAAC survey for 6-7 year olds
|
Single observation on day of recruitment
|
Symptoms of food allergy
Délai: Single observation of day of recruitment
|
Questionnaire based on Health Nuts survey
|
Single observation of day of recruitment
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Weight
Délai: Single observation on day of recruitment
|
Single observation on day of recruitment
|
|
Height
Délai: Single observation on day of recruitment
|
Single observation on day of recruitment
|
|
Mid-upper arm circumference
Délai: Single observation on day of recruitment
|
Single observation on day of recruitment
|
|
Hospitalisations
Délai: Single observation on day of recruitment
|
Single observation on day of recruitment
|
|
Infectious diseases
Délai: Single observation on day of recruitment
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History of chickenpox or measles
|
Single observation on day of recruitment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christine Benn, DMSc, Statens Serum Institut
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- 2013-VAS-Atopy
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